Act Dif 2 Guia de Operacion

COULTER ACT diff 2 Analyzer
Operators Guide
PN 4237495BA (August 2010)
Beckman Coulter, Inc. 250 S. Kraemer Blvd. Brea, CA 92821
WARNINGS AND PRECAUTIONS

READ ALL PRODUCT MANUALS AND CONSULT WITH BECKMAN COULTER-TRAINED PERSONNEL BEFORE ATTEMPTING TO OPERATE INSTRUMENT. DO NOT ATTEMPT TO PERFORM ANY PROCEDURE BEFORE CAREFULLY READING ALL INSTRUCTIONS. ALWAYS FOLLOW PRODUCT LABELING AND MANUFACTURERS RECOMMENDATIONS. IF IN DOUBT AS TO HOW TO PROCEED IN ANY SITUATION, CONTACT YOUR BECKMAN COULTER REPRESENTATIVE. HAZARDS AND OPERATIONAL PRECAUTIONS AND LIMITATIONS WARNINGS, CAUTIONS, and IMPORTANTS alert you as follows: WARNING - Can cause injury. CAUTION - Can cause damage to the instrument. IMPORTANT - Can cause misleading results. BECKMAN COULTER, INC. URGES ITS CUSTOMERS TO COMPLY WITH ALL NATIONAL HEALTH AND SAFETY STANDARDS SUCH AS THE USE OF BARRIER PROTECTION. THIS MAY INCLUDE, BUT IT IS NOT LIMITED TO, PROTECTIVE EYEWEAR, GLOVES, AND SUITABLE LABORATORY ATTIRE WHEN OPERATING OR MAINTAINING THIS OR ANY OTHER AUTOMATED LABORATORY ANALYZER. WARNING Risk of operator injury if: r All doors, covers and panels are not closed and secured in place prior to and during instrument operation. r The integrity of safety interlocks and sensors is compromised. r Instrument alarms and error messages are not acknowledged and acted upon. r You contact moving parts. r You mishandle broken parts. r Doors, covers and panels are not opened, closed, removed and/or replaced with care. r Improper tools are used for troubleshooting. To avoid injury: r Keep doors, covers and panels closed and secured in place while the instrument is in use. r Take full advantage of the safety features of the instrument. Do not defeat safety interlocks and sensors. r Acknowledge and act upon instrument alarms and error messages. r Keep away from moving parts. r Report any broken parts to your Beckman Coulter Representative. r Open/remove and close/replace doors, covers and panels with care. r Use the proper tools when troubleshooting. CAUTION System integrity might be compromised and operational failures might occur if: r This equipment is used in a manner other than specified. Operate the instrument as instructed in the Product Manuals. r You introduce software that is not authorized by Beckman Coulter into your computer. Only operate your systems computer with software authorized by Beckman Coulter. r You install software that is not an original copyrighted version. Only use software that is an original copyrighted version to prevent virus contamination. IMPORTANT If you purchased this product from anyone other than Beckman Coulter or an authorized Beckman Coulter distributor, and, if it is not presently under a Beckman Coulter service maintenance agreement, Beckman Coulter cannot guarantee that the product is fitted with the most current mandatory engineering revisions or that you will receive the most current information bulletins concerning the product. If you purchased this product from a third party and would like further information concerning this topic, call your Beckman Coulter Representative.
REVISION STATUS
Initial Issue, 2/99 Software Version 1.0 Issue B, 6/03 Changes were made to, r r comply with the EU IVD Directive (98/79/EC). change the company name from Coulter Corporation to Beckman Coulter Inc.
Issue BA, 08/10 Software Version 1.00. Updates were made to the company corporate address. Note: Changes that are part of the most recent revision are indicated in text by a bar in the margin of the amended page.
This document applies to the latest software listed and higher versions. When a subsequent software version changes the information in this document, a new issue will be released to the Beckman Coulter website. For labeling updates, go to www.beckmancoulter.com and download the most recent manual or system help for your instrument.
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REVISION STATUS
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CONTENTS
LEGAL NOTICES, ii REVISION STATUS, iii INTRODUCTION, xv HOW TO USE YOUR COULTER ACT diff 2 ANALYZER MANUALS, xv ABOUT THIS MANUAL, xvi CONVENTIONS, xvi GRAPHICS, xvi SYMBOLS, xvii Safety Symbols, xvii Procedure Symbols, xvii INSTALLATION PROCEDURES, xvii TOUCH SCREEN ICONS, xvii Screen Numbers, xvii Main Screen Icons, xviii Setup Screen Icons, xix QA Screen Icons, xix Diluter Functions Screen Icons, xx Diagnostic Functions Screen Icons, xx Sample Results Screen Icons, xxi Sample ID Screen Icons, xxi ICON TREE OVERVIEW, xxii ICON TREE DETAIL, xxiii 1 ROUTINE PROCEDURES, 1-1 1.1 1.2 2 STARTUP 1-1 , SHUTDOWN, 1-1
CELL CONTROLS, 2-1 2.1 ENTERING 4C PLUS CELL CONTROL INFORMATION, 2-1 Entering the Lot Number, 2-1 Entering Values, 2-4 RUNNING CONTROLS, 2-8 Running COULTER 4C PLUS Cell Control, 2-8 Printing Stored 4C PLUS Cell Control Results, 2-12 RUNNING LIN-C LINEARITY CONTROL, 2-14 DOWNLOADING 4C PLUS CELL CONTROL RESULTS FOR IQAP 2-19 ,
2.2
2.3 2.4
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CONTENTS
2.5 3
DELETING 4C PLUS CELL CONTROL FILES, 2-21
RUNNING SAMPLES, 3-1 3.1 3.2 GENERAL, 3-1 RUNNING WHOLE BLOOD SAMPLES, 3-2 Sample Analysis: Closed Vial Whole Blood Mode, 3-2 Sample Analysis: Open Vial Whole Blood Mode, 3-7 Sample Analysis: Open Vial Samples in the Closed Vial Whole Blood Mode, 3-10 RUNNING PREDILUTED BLOOD SAMPLES, 3-14
3.3 4
REVIEWING RESULTS, 4-1 4.1 PRINTING STORED SAMPLE RESULTS, 4-1 Printing Sample Results, 4-3
CALIBRATION, 5-1 5.1 5.2 5.3 5.4 5.5 5.6 OVERVIEW, 5-1 Recommended Calibrator, 5-1 BEFORE CALIBRATING, 5-2 PRECALIBRATION CHECKS, 5-2 REPRODUCIBILITY , 5-3 CARRYOVER, 5-7 AUTO-CALIBRATION, 5-10
SERVICE AND MAINTENANCE, 6-1 6.1 6.2 6.3 GENERAL MAINTENANCE, 6-1 Cycle Counter, 6-1 MAINTENANCE SCHEDULE, 6-1 CLEANING PROCEDURES, 6-3 Zapping the Aperture, 6-3 Cleaning (Bleaching) the Baths, 6-4 Cleaning the Outside of the Instrument, 6-7 Cleaning the Inside of the Instrument, 6-7 Cleaning the Closed Vial Station, 6-7 Cleaning the Closed Vial Door, 6-14 Cleaning the Fans Dust Filter, 6-16 CALIBRATION PROCEDURES, 6-18 ACT diff 2 ANALYZER COMPONENT LOCATIONS, 6-18 Inside Front, 6-18 Inside Right, 6-19
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6.4 6.5
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CONTENTS
6.6
REPLACEMENT PROCEDURES, 6-20 Replacing Reagents, 6-20 Replacing the diff ACT Pak Reagent, 6-20 Replacing the diff ACT Tainer Reagent, 6-25 Replacing the Ac T Rinse Shutdown Diluent, 6-31 Replacing the Waste Container, 6-33 Replacing the Vacuum Fluid Barrier, 6-34 Replacing Check Valves, 6-38 Replacing Tubing, 6-43 Replacing Fuses, 6-45 Replacing the Vacuum Isolator Chamber (VIC), 6-48 Adjusting the Vacuum, 6-55 Replacing the Probe Wipe, 6-57 Replacing the Tube Holder, 6-64 Replacing the Waste Filter, 6-68 , 6-68 PREPARING TO SHIP THE INSTRUMENT, 6-71 TROUBLESHOOTING, 6-77 Troubleshooting Tools, 6-77 Diluter Functions, 6-77 Diagnostic Functions, 6-78 PARAMETER CODES AND FLAGS, 6-80 Hierarchy of Flags, 6-80 Replacement Flags (Codes), 6-80 Non-Replacement Flags, 6-80
6.7 6.8
6.9
6.10 WHAT FLAGS AND CODES MEAN, 6-81 6.11 WHAT WARNING MESSAGES MEAN, 6-89 6.12 SYSTEM ERRORS , 6-91 6.13 TROUBLESHOOTING GUIDES, 6-93 A MANUAL CALIBRATION, A-1 A.1 A.2 A.3 B ANALYSIS PROCEDURE, A-1 CALCULATIONS PROCEDURE, A-4 CALCULATING NEW CALIBRATION FACTORS, A-5 Calibration Worksheet, A-7
TUBES AND ADAPTERS, B-1 B.1 B.2 B.3 TUBES, B-1 TUBE LIMITATIONS, B-2 TUBE ADAPTER, B-3
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CONTENTS
REFERENCES, REFERENCES-1 GLOSSARY, GLOSSARY-1 ABBREVIATIONS, ABBREVIATIONS-1 INDEX, INDEX-1 TRADEMARKS, 1-11 COULTER ACT diff 2 Analyzer Documentation, 1-12
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TABLES
6.1 6.2 6.3 6.4 6.5 6.6 6.7 6.8 6.9 6.10 B.1 B.2 B.3 Maintenance Schedule, 6-1 Diluter Functions Screen, 6-77 Diagnostic Functions Screen, 6-79 What Flags Mean, 6-81 Warning Messages, 6-89 System Errors, 6-91 Power Problems, 6-93 Aspiration Problems, 6-94 Background Problems, 6-95 Irregular Sample Results, 6-97 Closed Vial Sample Tubes, B-1 Types of Tubes Not For Use with ACT diff 2 Analyzer, B-2 Tube Adapter Usage, B-3
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INTRODUCTION
This introductory section contains the following topics: s s s s s s s s s How to use your COULTER ACT diff 2 Analyzer Manuals About this Manual Conventions Graphics Symbols Installation Procedures Touch Screen Icons Icon Tree Overview Icon Tree Detail
HOW TO USE YOUR COULTER ACT diff 2 ANALYZER MANUALS

Use this Operator's Guide for: s s s s s Getting started Running your instrument day to day Reviewing unusual results, including how to read a result report and what flags mean Performing special procedures such as cleaning, replacing, or adjusting a component of the instrument Troubleshooting problems with your instrument.
Use the Reference manual for in-depth information about: s s s s s s What the instrument does What special requirements the instrument has (for example, space, accessibility, power) What methods it uses What the instrument specifications are How to interface your ACT diff 2 analyzer to your laboratorys host computer How to safely use the instrument.
Use the Operating Summary for: s s Running your instrument using a quick reference set of procedures Verifying screen icon definitions
Use the Installation and Training Guide for: r r r r Initially setting up the instrument and printer Powering up the instrument Customizing the software Running controls and samples
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INTRODUCTION ABOUT THIS MANUAL
ABOUT THIS MANUAL

This information in this manual is organized as follows: s s s s s Chapter 1, Routine Procedures Contains the startup and shutdown procedures. Chapter 2, Cell Controls Contains information on 4C PLUS cell control. Chapter 3, Running Samples Contains information on how to run whole blood and prediluted blood samples. Chapter 4, Reviewing Results Contains information on how to review current and stored sample results. Chapter 5, Calibration Contains the procedures for reproducibility, carryover, and auto-calibration. Also includes precalibration checks. Chapter 6, Service and Maintenance Contains information on the special procedures and troubleshooting procedures for the instrument. Covers topics such as cleaning, calibration, replacement and adjustment procedures, as well as defining flags and codes. Appendix A, Manual Calibration Contains the procedures for manual calibration when S-CAL calibrator is not available. Appendix B, Tubes and Adapters Contains a list of approved tubes and tube adapters for use with the instrument. This manual also includes a Glossary, Abbreviations list, recommended References, and an Index.
s s s
CONVENTIONS
This manual uses the following conventions: Bold font indicates ACT diff 2 analyzer manual titles. Bold indicates a screen icon. Italics font indicates screen text displayed by the instrument. Instrument refers to the ACT diff 2 analyzer. A Note contains information that is important to remember or helpful in performing a procedure.
GRAPHICS
All graphics, including screens and printouts, are for illustration purposes only and must not be used for any other purpose.
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INTRODUCTION SYMBOLS
SYMBOLS
Safety Symbols
Safety symbols alert you to potentially dangerous conditions. These symbols, together with text, apply to specific procedures and appear as needed throughout this manual.
Symbol Warning Condition Biohazard.Consider all materials (specimens, reagents, controls, and calibrators, and so forth) as being potentially infectious. Probe hazard. The probe is sharp and may contain biohazardous materials, including controls and calibrators. Electrical shock hazard. Possibility of electrical shock when instrument is plugged in to the power source. Action Wear standard laboratory attire and follow safe laboratory procedures when handling any material in the laboratory. Avoid any unnecessary contact with the probe and probe area.
! ! !
Before continuing, unplug the ACT diff 2 analyzer from the electrical outlet.
Procedure Symbols
Procedure symbols give direction.
Symbol Definition Go to step number. Action
Go to the step number that appears after the icon. See Special Procedures and Troubleshooting in this manual for additional information.
Special Procedures and Troubleshooting
INSTALLATION PROCEDURES
See the Installation and Training Guide for installation procedures.
TOUCH SCREEN ICONS

Screen Numbers
A number appears next to the title icon on a screen. The number is unique to that screen and is significant only as a screen identifier; the number does not print on any reports.
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INTRODUCTION TOUCH SCREEN ICONS
Main Screen Icons
Setup
Startup
Diluter Functions
Shutdown
Diagnostics
Analyzing Mode
Open Vial Whole Blood Mode
Closed Vial Whole Blood Mode
Predilute Mode
Quality Assurance
Darken Screen
Lighten Screen
Sample Results Screen
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Setup Screen Icons
Units
Transmission
Patient Limits
Calibration Factors
Date/Time
Printers/Profiles
Laboratory ID
Exit
Print Setup Report
QA Screen Icons
4C PLUS Cell Control Run
Calibration
4C PLUS Management
Reproducibility
4C PLUS Limits
Carryover
Exit
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Diluter Functions Screen Icons
Wet Prime
Dispense Lytic Reagent
Drain Baths
Prime Sweepflow
Rinse + Mix
Zap Apertures
Dry Prime Lytic Reagent
Clean Baths
Dry Prime Diluent
Exit
Diagnostic Functions Screen Icons
Voltages/Sensors
Motors
Solenoids
Pulse Test
Verify Predilute
Latex Calibration
Sample Details
Prepare to Ship
Cycle Counter
Do
Exit
not use this function without proper instruction from your Beckman Coulter Representative.
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Sample Results Screen Icons
Dispense Diluent
Go to Main Menu
Resend to Host
Enter Patient ID
Retrieve Stored Data (Predilute results screen shown here.) Print Sample Results
Do
In Progress
Patient Limits
not use this function without proper instruction from your Beckman Coulter Representative.
Sample ID Screen Icons
Next Sample ID
Save and Exit
Delete
Exit
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INTRODUCTION ICON TREE OVERVIEW
ICON TREE OVERVIEW

Here is an overview of the icon tree. For additional information, see Touch Screen Icons and Icon Tree Detail.
POWERUP SCREEN
STARTUP SCREEN SETUP FUNCTIONS
Title icon screen number. Used as a screen reference. Not all screens have title icon numbers. MAIN SCREEN STARTUP
UNITS
DILUTER FUNCTIONS SHUTDOWN WET PRIME VOLTAGES/ SENSORS DRAIN BATHS SOLENOIDS DRY PRIME LYTIC REAGENT CONTROL RUN DIAGNOSTICS FUNCTIONS ANALYZING MODE SAMPLE RESULTS DARKEN LIGHTEN SCREEN SCREEN
PATIENT LIMITS
QA FUNCTIONS
DATE/TIME
TRANSMISSION DISPENSE LYTIC REAGENT CALIBRATION FACTORS ZAP APERTURES PRINTERS/ PROFILES RINSE + MIX LABORATORY ID DRY PRIME DILUENT PRINT SETUP REPORT SWEEP FLOW
VERIFY PREDILUTE
4C PLUS MANAGEMENT
SAMPLE DETAILS
ASSAY VALUES AND RANGES
MOTORS
CALIBRATION ASSIGNED VALUES
PULSE REPRODUCIBILITY RUN LATEX CALIBRATION CARRYOVER RUN PREPARE TO SHIP
CLEAN BATHS
CYCLE COUNTER
7515001A
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ICON TREE DETAIL
ICON TREE DETAIL

POWERUP SCREEN
(20) UNITS TRANSMISSION CALIBRATION FACTORS PATIENT LIMITS (21) PRINTERS/ PROFILES (22&23) DATE/TIME (24) LABORATORY ID (27) (26) ZAP APERTURES WET PRIME (25) DRY PRIME LYSE DISPENSE LYSE
STARTUP SCREEN (70)
(30)
MAIN SCREEN (10) SETUP FUNCTIONS STARTUP DILUTER FUNCTIONS
DRAIN BATHS
CLEAN BATHS DIAGNOSTICS FUNCTIONS DRY PRIME DILUENT
SHUTDOWN ANALYZING MODE SAMPLE RESULTS
RINSE + MIX
SWEEP FLOW
QA FUNCTIONS
(1)
(40) VOLTAGES/SENSORS SOLENOIDS VERIFY PREDILUTE MOTORS PULSE HEIGHT LATEX SIZE CONTROL RUN CONTROL INFO ASSAY VALUES AND RANGES
(50) CALIBRATION ASSIGNED VALUES REPRODUCIBILITY RUN CARRYOVER RUN SAMPLE ID
SAMPLE DETAILS (51) PREPARE TO SHIP (42) (52) (58) (55)
(45)
(53 & 54))
(59) CALIBRATION RUN (56)
PULSE TEST (47) CARRYOVER SUMMARY
LATEX CALIBRATION RUN
(60)
Note: Screen numbers are in parentheses above the screen for ease of reading. These numbers are for reference when troubleshooting. Not all screens have numbers.
(57)
CALIBRATION SUMMARY
7515019A
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ICON TREE DETAIL
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1ROUTINE PROCEDURES 1
1.1 STARTUP
When you turn on the instrument, it automatically performs the startup procedure. If you want to have the instrument do the startup procedure again when the instrument is on, follow this procedure. Do this procedure daily.
At the Main screen, touch the Startup icon.
The instrument performs the startup routine and reports a PASS or FAIL for the WBC, RBC, Hgb, and Plt parameters.
1.2
SHUTDOWN
Before you turn the instrument off, do this shutdown procedure. Do this procedure daily. If you consistently run less than 5 samples per day, you can do this procedure every other day.
At the Main screen, touch the Shutdown icon.
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1-1
ROUTINE PROCEDURES SHUTDOWN
When this screen appears, you can turn off the instrument.
1-2
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2CELL CONTROLS 2
2.1 ENTERING 4C PLUS CELL CONTROL INFORMATION
Before running controls, the values from the TABLE OF EXPECTED RESULTS in the assay sheet must be entered and saved into the instrument for each lot of controls. When operating this instrument outside the optimal temperature range (20 - 25C), control results may exceed the expected limits. One of the suggested corrective actions is to establish your own mean values that are appropriate for your laboratorys environment. These values should be entered and saved in the instrument. The mean value you establish should not exceed the expected range limits determined for the control material at optimal temperature. If this occurs, contact your Beckman Coulter Representative.
IMPORTANT Risk of existing data in the database not being flagged using new values or ranges. If the Expected Values or Range is edited and saved when the control database is not empty, samples run after the change will be flagged according to the edited values; however, the data already in the database will not be reflagged based on the new values or ranges. The new values will be printed with the control summary data. Be sure to edit/save Expected Values or Ranges only when the control database is empty.
Entering the Lot Number 1

Be sure you have the 4C PLUS cell control.
4C Plus
COULTER CELL CONTROL
! !
TM
R TE UL CO LL CE L RO NT CO
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CELL CONTROLS ENTERING 4C PLUS CELL CONTROL INFORMATION
At the Main screen, touch the QA icon.
At the QA screen, touch the 4C Management icon.
Select the cell control level (L, N, or H) by touching the level indicator. r r r r
A = all (Not for use when entering the lot number or expiration date.) L = low N = normal H = high
The square darkens next to your selection.
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Enter the lot number: a. Touch the Lot# field.
b.
Enter the lot number located on the vial (up to 6 digits).

T LO
1 4 7
T LO
2 5 8
3 6 9
00 74 07
00 74 07
P. EX C ) 2-8 F at 046 re 5 (3 Sto
9 T9 OC 13
Enter the expiration date: a. Touch the Exp. field.
b.
Enter the expiration date (up to 6 digits) in MMDDYY format. Use a dash to separate the month from the day and the day from the year. For example, to enter October 13, 1998, you would press 10-13-98 at the keypad.
1 4 7
C ) 2-8 F at 46 re 50 (3 Sto P. EX T LO
2 5 8
3 6 9
00 74 07
T P. C EX 3O 1
e or (35 9 St T9 OC 13
98
C 8 ) 2- F at 046
Print the information you entered by touching the Print icon.
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Save the information by touching the Save and Exit icon.
Do the Entering Values procedure.
Entering Values
IMPORTANT Risk of misleading results if improper values are entered. If you are not using 4C PLUS cell control, DO NOT do this procedure.
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At the QA screen, touch one of the 4C Parameter icons.
Select the control level: r r r

L = low N = normal, or H = high.
Refer to the TABLE OF EXPECTED RESULTS supplied with your control material.

TABLE OF EXPECTED RESULTS
4CPLUS
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On the screen, touch the parameter field where you want to enter the assay values. At the keypad, enter the corresponding expected range from the TABLE OF EXPECTED RESULTS.
1 4 7
2 5 8
3 6 9
. 0
To save the data you enter while remaining at the current screen touch the middle icon at the bottom right of the screen. (L, N, or H appears above the Save icon to reflect the control level.) Note: This is recommended if your laboratory experiences electrical fluctuations or brownouts.
When you are ready to save and exit this screen, touch the Save and Exit icon.
OK
Repeat steps 1 through 7 until target values are entered for all levels.
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To print the values you entered: a. Return to the QA screen and touch the 4C Management icon.
b.
Select A for all.
c.
Touch the Print icon.
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CELL CONTROLS RUNNING CONTROLS
2.2
RUNNING CONTROLS
The control for the ACT diff 2 analyzer is 4C PLUS cell control. When operating this instrument outside the optimal temperature range (20 - 25C), control results may exceed the expected limits. One of the suggested corrective actions is to establish your own mean values that are appropriate for your laboratorys environment. These values should be entered and saved in the instrument. The mean value you establish should not exceed the expected range limits determined for the control material at optimal temperature. If this occurs, contact your Beckman Coulter Representative.
Running COULTER 4C PLUS Cell Control 1

Be sure the 4C PLUS cell control information and values have been correctly entered from the TABLE OF EXPECTED RESULTS in the assay sheet. For information on how to enter the values, see Entering Values in this chapter.

TABLE OF EXPECTED RESULTS
4CPLUS
Ensure that the 4C PLUS cell control is not past its expiration date and that it is at the correct storage temperature.
C 8 2
P. EX C ) 2-8 F at 46 re 50 (3 Sto T LO
F 46 35
00 74 07
T P. C EX 3O 1
e or (35 9 St T9 OC 13
98
C 8 ) 2- F at 046
After warming at room temperature, mix each control gently according to instructions in the cell control package insert. Inspect the vial contents to ensure that all cells are uniformly distributed; if not, repeat this step.
8x
8x
8x
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At the QA screen, touch the 4C PLUS Run icon.
Select the correct control level:

L - for low N - for normal H - for high
The square darkens next to your selection. If the selected control level has expired, the Control Expired icon appears in the lower left corner of the screen.
Make sure that the level of control you are testing matches the one selected (L, N, or H).
TE UL CO R LL CE
L RO
R NT CO OL
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Invert the tube once or twice prior to cycling.

IMPORTANT Risk of misleading results if Cap Pierce Station door is open before the sample analysis is completed. Do not open the door. The door will open automatically.
Place the well-mixed sample in the tube holder at the Cap Pierce Station and close the door. Note: If the door is inadvertently closed after it has opened automatically, or if it is closed at a screen where samples are not run, you can open the door by returning to the Main Menu screen and then touching the Sample Results icon. After opening the door, return to the Main Menu screen then return to step 4.
COU LTE R CEL L CON TRO L
10 When the tube holder door opens, remove

the vial and return it to the refrigerator.
COU LTE R CEL L CON TRO L
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11 Results appear on the screen.

r Unless non-numeric results occur for one or more parameters, the control results are automatically stored.
If Autoprint is off, you can manually print the results.
To manually reject these results, touch the Trash icon. See Special Procedures and Troubleshooting in this manual for information on reviewing flagged results. If results are not within the expected range, rerun the control starting at step 7. If results are still out of range, see Special Procedures and Troubleshooting in this manual.
12 Repeat steps 6 through 11 for each

required control level.
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13 If the results are within the expected

range, you are finished running controls. If you do all of the above steps and the results still do not meet your performance expectations, call your local Beckman Coulter Representative.
Printing Stored 4C PLUS Cell Control Results 1

! !
At the QA screen, touch the 4C PLUS Management icon.
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Select the control level you want to print: r r r r

A = all L = low N = normal H = high
The square darkens next to your selection. Note: If you are using a ticket printer, you cannot select level A.
Touch the appropriate Print icon for the data you want: r Touch the Print icon to print the assay values currently in the system.
Touch the Print Summary icon to print a summary of the control data. If you have a graphic printer, touch the Graph icon to print a Levey-Jennings graph of the control data.
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CELL CONTROLS RUNNING LIN-C LINEARITY CONTROL
2.3
RUNNING LIN-C LINEARITY CONTROL

The procedure for running LIN-C linearity control is provided below. For all other information regarding LIN-C linearity control, refer to the package insert.
Remove the LIN-C linearity controls from the refrigerator and warm at ambient room temperature for 15 minutes.
R TE UL CO Y IT AR NE LI
M L mL RO 3.3 NT CO ID E NG RA
At the Main screen, select Closed Vial Whole Blood mode.
! !
At the Main screen, touch the Sample Results Screen icon. Note: If the door is inadvertently closed after it has opened automatically, or if it is closed at a screen where samples are not run, you can open the door by touching the Main Menu icon and then the Sample Results icon.
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Gently mix the control.
8x
8x
8x
Inspect the tube contents to ensure complete resuspension of the contents. If contents are not uniformly resuspended, repeat step 4.
Place a lint-free tissue over the top and remove the cap.
! !
COULTER LINEARITY CONTROL COULTER CELL CONTROL
3.3mL MID RANGE
Be sure you are in the Closed Vial Whole Blood mode.
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IMPORTANT Risk of misleading results if Cap Pierce Station door is open before the sample analysis is completed. Do not open the tube holde The tube holder will open automatically.
Place the well-mixed control in the tube holder at the Cap Pierce Station and close the door. Note: If the door is inadvertently closed after it has opened automatically, or if it is closed at a screen where samples are not run, you can open the door by touching the Main Menu icon and then the Sample Results icon.
COU LTE R LINE ARIT Y CON TRO L

3.3m L MID RAN GE
Replace the cap securely on the vial.
COULTER LINEARITY CONTROL COULTER CELL CONTROL
3.3mL MID RANGE
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10 Record the results for WBC, RBC, Hgb,

and Plt parameters on the Worksheet. Repeat flagged samples with non-numeric results. Note: Beckman Coulter recommends that five sample results be used to calculate the mean value. A minimum of three samples must be used to calculate the mean when repetitive results with non-numeric values occur.
LIN-C/COULTER LINEARITY CONTROL
WORKSHEET
ACCOUNT INFORMATION Name Address City / State Contact Telephone
Startup Background Counts WBC_________RBC__________Hgb___________Plt___________ Lot No. WBC RBC Exp. Date HGB PLT
Ultra Low
Run 1 (Prime) Run 2 Run 3 Run 4 Run 5 Run 6 Mean (2 thru 6) High Limit Low Limit
OP ID
Instrument model Serial Number IQAP Participant Number
Test Date
Low
Lot No. WBC RBC
Exp. Date HGB PLT
Instructions: 1. Complete all accoutnand instrument information above. NOTE: If this kit is used on multiple instruments, make copies of the form prior to entering data. 2. Record instrument start up background counts.
3. Record the six runs of each range for WBC, RBC, HGB and PLT. 4. Calculate the mean of runs 2 thru 6. [(Run 2 + .... + Run 6) / 5] 5. Record the high and low limits from the Table of Expected Results on the Product Insert. 6. Plot your mean and the gigh and low limits on the vertical line which corresponds to each range of control. Plot your instrumnent's startup background counts. See the reverse side of the second page for an example. Values should fall whthin the high and low limit. 7. To receive a tabular summary and graphic present ation, submit the top copy to: Coulter IQAP Mailcode 31-B04 PO Box 169015 Miami, FL 33116-9015 You may submit this sheet with your next IQAP mailing. 8. Alternative methods for data submission are detailed on reverse side of the second page.
Mid
Lot No. WBC RBC
Exp. Date HGB PLT
High
Lot No. WBC RBC
Exp. Date HGB PLT
Ultra High
Lot No. WBC RBC
Exp. Date HGB PLT
11 Repeat steps 4 through 9 five more

times for a total of six runs.
12 Delete the first sample result.
13 Calculate the mean from the last five

sample results.
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14 Plot the mean recovered values on the

LIN-C linearity control graphs.
I nst . Ser ial No.: Dat e: Oper at or : 100 9 0 80 70 60 50 40 30 20
L I N-C COUL T ER L I NEARI T Y CONT ROL /

L ot Num s: ber Ul t r a L ow : L ow : Mid: H : igh Ul t r a H : igh
100 9 0
W BC
x103/ uL
80 70 60 50 40 30 20 3
Re cov e e r d
Ul t r a L ow
L ow
Mid
H igh
Ul t r a H igh
RBC
x106/ uL
Re cov e e r d
Ul t r a L ow
L ow
Mid
H igh
Ul t r a H igh
15 Compare the mean value to the

linearity control ranges listed on the Table of Expect Results in your package insert.
16 Plot your instruments Startup

background count results as a zero value on the control graphs to extend the reportable range.
17 Submit your Worksheet data to IQAP

departments at the address on the Worksheet. After you submit your data, Beckman Coulter prepares tabular summaries and graphic presentations of your data.
2-18
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CELL CONTROLS DOWNLOADING 4C PLUS CELL CONTROL RESULTS FOR IQAP
2.4
DOWNLOADING 4C PLUS CELL CONTROL RESULTS FOR IQAP

Stored control results can be returned for inclusion in the IQAP program. Submit your IQAP data each month after completing your last set of controls. For additional information on the IQAP program, see the Reference manual. Note: Prior to downloading your data, ensure that your IQAP ID has been entered into your instrument. Without the IQAP ID, your data cannot be automatically processed. Refer to the Installation and Training Guide for information on entering your IQAP ID. Save used reagent management cards to use for this procedure. A card is ready for use for IQAP when you see this icon appear on your instrument:
Apply the IQAP identification label to a usedreagent management card, using care not to cover up the microchip (gold square).
Remove the current ACT diff reagent management card and insert a used reagent management card into the instrument.
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CELL CONTROLS DOWNLOADING 4C PLUS CELL CONTROL RESULTS FOR IQAP
At the 4C Management screen: a. b. Select A for all levels of control. Touch the IQAP icon to download (send) the data to the card.
Touch the Print Summary icon to print the control summaries. Keep a copy of the control file data, if possible, for your records. Note: If you are unable to download the data, submit your control data using a form approved by the IQAP department.
2-20
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CELL CONTROLS DELETING 4C PLUS CELL CONTROL FILES
Place the following items into the mailer: r r Reagent card with stored control data and attached label Copy of the control data.
Return the mailer to Coulter IQAP department. Note: At the time of enrollment in the IQAP program, you were supplied with pre-addressed mailers and self-adhesive return labels with your IQAP number. If you need additional information, contact your local Beckman Coulter Representative.
2.5
DELETING 4C PLUS CELL CONTROL FILES

indicates that one or more of your 4C PLUS cell control files are full and the instrument cannot store any additional control information. If you want to delete existing control files, follow this procedure. Once deleted, the control files cannot be recovered. Therefore, be sure that you have all the control information you need before deleting anything.
If your laboratory is an IQAP participant, download all the control data before proceeding to step 2. See Heading 2.4 for details. If your laboratory is not an IQAP participant, go to step 2 below.
! !
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Select the control level you want to print. r r r r

A = all L = low N = normal H = high
Print any control summaries or graphs needed for your records. r To print a summary, touch the Print Summary icon.
To print a graph, touch the Print Graph icon.
2-22
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Touch the Trash icon to delete the control files for the level of control you selected in step 4.
The Delete Confirmation screen appears. r r Touch the Trash icon to delete Touch the Return icon to return to the previous screen without deleting.
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2-24
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3RUNNING SAMPLES 3
3.1 GENERAL
When the ACT diff 2 analyzer is set to the correct analyzing mode (Closed Vial Whole Blood, Open Vial Whole Blood, or Predilute), and you have verified the sample ID, you are ready to run samples. You can analyze and print sample results with an associated range (1, 2, or 3). You can also elect to print sample results using the instruments linearity range (0). Displayed and printed results will be flagged based on the range selected when the sample was run. To ensure that the blood specimen is analyzed correctly, you must set the instrument to the correct analyzing mode. When storing samples: r r r Do not refrigerate samples for Platelet and differential counts. If you do not need Platelet or differential results, you can store whole-blood specimens drawn in a salt of EDTA at 2 to 8C. Warm samples to room temperature before you cycle them.
To record the sample results correctly, you must ensure that the ID number is correct.
IMPORTANT Risk of misleading results. Running a blood sample in an incorrect analyzing mode can cause wrong results. Only run a whole blood sample in the Whole Blood mode.
Beckman Coulter suggests that: r r r r You analyze a whole blood sample within 24 hours of collection. You analyze samples at the systems operating temperature (16-35C). You warm samples to room temperature before you analyze them. If flags appear for a sample, you refer to Table 6.4.
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RUNNING SAMPLES RUNNING WHOLE BLOOD SAMPLES
3.2
RUNNING WHOLE BLOOD SAMPLES

You can run whole blood samples in the Closed Vial Whole Blood (CVWB) mode or the Open Vial Whole Blood (OVWB) mode. When running samples in the CVWB mode, you leave the cap on the sample tube. When running samples in the OVWB mode, you remove the cap from the sample tube. Note: You can run open vial samples in the Closed Vial Whole Blood mode. Refer to the procedure entitled Sample Analysis: Open Vial Samples in the Closed Vial Whole Blood Mode.
Sample Analysis: Closed Vial Whole Blood Mode
Be sure the tubes and/or tube adapters you are using comply with those listed in Appendix B of this manual.
! !
3-2
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At the Main screen, touch the Sample Results Screen icon. Note: If the door is inadvertently closed after it has opened automatically, or if it is closed at a screen where samples are not run, you can open the door by touching the Main Menu icon and then the Sample Results icon.
Touch the Patient Range icon until the desired range (1, 2, or 3) appears. Note: 0 is not a patient range; it is the instruments linearity limit.
Verify that the sample ID is correct: r If autosequencing is on, the 9-digit sample ID number automatically increments by 1.
If autosequencing is off, manually enter the sample ID and touch the Save icon. Be careful not to duplicate an existing sample ID number that may have been previously autoincremented. Note: If you try to run another sample using the same ID, a warning will be displayed as a reminder to enter another ID.
4 7
5 8
6 9 0
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3-3
Mix the sample according to your laboratorys protocol.
! !
8x
IMPORTANT Risk of misleading results if Cap Pierce Station door is open before the sample analysis is completed. Do not open the tube holder. The tube holder will open automatically.
Place the well-mixed sample in the tube holder at the Cap Pierce Station and close the door. Note: If the door is inadvertently closed after it has opened automatically, or if it is closed at a screen where samples are not run, you can open the door by touching the Main Menu icon and then the Sample Results icon.
3-4
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When the tube holder door opens, remove the tube.
10 The sample results are automatically saved

by the instrument and the results appear on the screen.
11 Print the results:

r r If Autoprint is on, the results print automatically. If Autoprint is off, touch the Print icon.
If the printout is illegible, unclear, or incomplete, correct the printer problem and reprint.
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12 If autosequence is on, the instrument is

ready to run the next sample. If autosequence is off, you must manually enter an ID number before the probe descends for the next sample. If flags appear, see Special Procedures and Troubleshooting in this manual.
H
3-6
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Sample Analysis: Open Vial Whole Blood Mode
At the Main screen, select Open Vial Whole Blood mode.
! !
At the Main screen, touch the Sample Results Screen icon.
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3-7
Verify that the sample ID is correct: r If autosequencing is on, the sample ID number automatically increments by 1.
If autosequencing is off, manually enter the sample ID and touch the Save icon. Be careful not to duplicate an existing sample ID number that may have been previously autoincremented.
4 7
5 8
6 9 0
Note: If autosequencing is off, the probe does not descend until you manually enter and save the next ID.
Mix the sample according to your laboratorys protocol, and place a lint-free tissue over the top and remove the cap.
! !
Be sure you are in the Open Vial Whole Blood mode.
3-8
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Present the well-mixed sample to the probe so that the tip is well into the tube, and press the aspirate switch.
When you hear the beep, remove the sample, and put the cap back on the tube.
The sample results are automatically saved by the instrument, and the results appear on the screen.

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3-9

ready to run the next sample. If autosequence is off, you must manually enter an ID number before the probe descends for the next sample. If flags appear, see Special Procedures and Troubleshooting in this manual.
H
Sample Analysis: Open Vial Samples in the Closed Vial Whole Blood Mode
You can analyze an open vial (uncapped) sample in the Closed Vial Whole Blood mode.
!
WARNING Risk of biohazard condition. The level of the vial contents must be at least a half inch below the top of the vial when running an uncapped (open vial) sample in the Closed Vial Whole Blood mode.
Be sure the tubes and/or tube adapters you are using comply with those listed in Appendix B of this manual.
! !
3-10
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At the Main screen, touch the Sample Results Screen icon. Note: If the door is inadvertently closed after it has opened automatically, or if it is closed at a screen where samples are not run, you can open the door by going touching the Main Menu icon and then the Sample Results icon.
Verify that the sample ID is correct: r If autosequencing is on, the sample ID number automatically increments by 1.
If autosequencing is off, manually enter the sample ID and touch the Save icon. Be careful not to duplicate an existing sample ID number that may have been previously autoincremented. Note: If you try to run another sample using the same ID, a warning will be displayed as a reminder to enter another ID.
4 7
5 8
6 9 0
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Mix the sample according to your laboratorys protocol.
! !
Place the well-mixed sample in the tube holder at the Cap Pierce Station and close the door. Note: If the door is inadvertently closed after it has opened automatically, or if it is closed at a screen where samples are not run, you can open the door by going touching the Main Menu icon and then the Sample Results icon.
3-12
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When the tube holder door opens, remove the tube.
10 The sample results are automatically saved

by the instrument and the results appear on the screen.

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RUNNING SAMPLES RUNNING PREDILUTED BLOOD SAMPLES

ready to run the next sample. If autosequence is off, you must manually enter an ID number before the tube holder door opens for the next sample. If flags appear, see Special Procedures and Troubleshooting in this manual.
H
3.3
RUNNING PREDILUTED BLOOD SAMPLES

If it is your laboratorys procedure to collect specimens for hematology via capillary collection into a microcollection device, you may run the specimen in the whole blood mode. However, the Predilute mode should be used if the specimen collected cannot be directly aspirated in a whole blood mode. The Predilute mode dispenses 1580 L of diluent into an empty tube or receptacle where 20 L of capillary blood will be added, thereby diluting it, to create an adequate amount of sample volume for the instrument to aspirate for analysis.
IMPORTANT Risk of misleading results. Running a blood sample in an incorrect analyzing mode can cause wrong results. Only run prediluted blood in the Predilute mode.
Beckman Coulter suggests that: r r r r r r You analyze prediluted specimens for CBC within 4 hours of collection/preparation. You analyze prediluted specimens for diff within 1 hour of collection/preparation. You allow a prediluted sample to stabilize in the predispensed diluent for at least 5 minutes. If flags appear, you refer to Special Procedures and Troubleshooting in this manual. You analyze at system operating temperature (16-35C). Each laboratory evaluate predilute stability based on their sample population and specimen collection techniques or methods.
Note: Prediluted samples require analysis in the Predilute mode.
3-14
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At the Main screen, select the Predilute mode.
! !
At the Main screen, touch the Sample Results Screen icon. r r If preparing prediluted samples, do steps 3 through 5. If dilutions are already prepared, go to step 7.
Touch the Dispense Diluent icon. The aspiration probe then retracts into the instrument and descends again.
Present an empty tube to the probe and press the aspirate switch to dispense 1580 L of diluent into the empty tube. When all your samples are prepared, touch the Exit icon to return to the Sample Results Screen.
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Prepare the sample for analysis: a. b. c. Add 20 L of blood specimen to the diluent in the tube. Mix the sample according to your laboratorys protocol. Wait at least 5 minutes before running the sample.
20 L 1580 L
Repeat steps 3 through 5 for each sample.
Be sure you are in the Predilute mode.
3-16
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Verify that the sample ID is correct: r If autosequencing is on, the sample ID number automatically increments by 1. If autosequencing is off, manually enter the sample ID and touch the Save icon. Be careful not to duplicate an existing sample ID number that may have been previously autoincremented.
1 2 3 4 7 5 8 6 9 0
Note: If autosequencing is off, the probe does not descend until you manually enter and save the next ID.
10 Present the well-mixed, prediluted sample

to the probe and press the aspirate switch. When you hear the beep, remove the sample.
11 The ACT diff 2 analyzer displays the

sample results on the screen and automatically saves them.
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3-17

13 If flags appear, see Special Procedures and

Troubleshooting in this manual.
H

ready to run the next sample. If autosequence is off, you must manually enter an ID number before the probe descends for the next sample.
3-18
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4REVIEWING RESULTS 4
4.1 PRINTING STORED SAMPLE RESULTS
The instrument automatically saves (stores) up to 250 patient results (numerical only, excluding histograms). Results are saved after sample analysis is completed. There may be times when you need to review certain patient results that were saved. You can recall patient results based on the date of analysis. This procedure explains how to do that. This function is available for use with the graphic printer only.
At the Main screen, touch the Sample Results Screen icon.
At the Sample Results Screen, touch the Retrieve Stored Data icon.
A screen with date fields appears. The date field on the left is the from date field, and the date field on the right is the to date field.
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REVIEWING RESULTS PRINTING STORED SAMPLE RESULTS
Enter the date range of the samples you want to review. a. b. Enter the beginning date of the sample results you want. Enter the ending date of the sample results you want.
Note: Be sure to use the dash to separate the month-day-year, such as 01-01-99.
Touch the Print Summary or Report icon to print the results. The In Progress icon appears on the screen during printing.
OK
A report prints out similar to that shown here. The report reflects only the sample data saved for only the date range that you entered. Note: In case of multiple samples with the same sample ID#, use the date and time to differentiate the runs.
4-2
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Printing Sample Results

You can print sample results with an associated range (1, 2, or 3). You can also select to print sample results using the instruments linearity range (0). Displayed and printed results are flagged based on the range selected when the sample was run.
At the Main screen, touch the Sample Results icon.
Touch the Patient Range icon until the desired range (1, 2, or 3) appears. Note: 0 is not a patient range; it is the instruments linearity limit. Flagging of results is done at the time the sample is analyzed. Changing the patient range after the sample was analyzed will not change the flagging. A new selected patient range will be reflected on the printout only when a new sample is processed.
Touch the Print icon to print.
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4-4
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5CALIBRATION 5
5.1 OVERVIEW
Beckman Coulter calibrates the ACT diff 2 analyzer at the factory before shipment, and the calibration data is provided with your instrument documentation. You may need to perform calibration procedures when you replace any instrument component that involves the primary measurement characteristics (such as an aperture). Because the instrument is electronically stable, it should not require frequent recalibration when you operate it and maintain it according to the recommendations in this manual. Make the decision to recalibrate based on the performance of your quality control program. Beckman Coulter recommends that you calibrate your instrument according to the regulations required by your inspecting agency. Your laboratorys quality control program should continually monitor and confirm instrument calibration. Review your control results periodically. Keep a written record of this review. To confirm calibration of the ACT diff 2 analyzer: 1. 2. Verify that 95% of control results are within their ranges as listed in the TABLE OF EXPECTED RESULTS. Verify that there are no unexplained shifts or trends in the data.
If recalibration appears necessary, but you have not replaced a component affecting calibration, do NOT recalibrate the instrument. 1. 2. First, thoroughly clean your analyzer following the Clean the Baths procedure in Chapter 6 of this manual. Then reanalyze a new vial of control material. r r If the control results are still outside of the expected ranges, refer to Table 6.10 and Heading 6.12 in this manual. If the results remain outside the expected ranges, call your Beckman Coulter Representative before recalibrating.
When necessary, perform calibration by following the procedures given in this section. Before you begin calibration, be sure you have enough reagents to perform the complete procedure. If you run out of reagents during calibration, you must start over and perform a complete calibration.
Recommended Calibrator
Beckman Coulter recommends using S-CAL calibrator for automated calibration. If S-CAL calibrator is not available, manual calibration can be done after Reproducibility and Carryover are completed. See Appendix A for the manual calibration procedure. You can calibrate either automatically or manually, using S-CAL calibrator.
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CALIBRATION BEFORE CALIBRATING
5.2
BEFORE CALIBRATING
Before calibrating, you must first prepare the instrument: 1. 2. 3. Do Heading 5.3, PRECALIBRATION CHECKS. Do Heading 5.4, REPRODUCIBILITY. Do Heading 5.5, CARRYOVER.
5.3
PRECALIBRATION CHECKS
1
Be sure that all required maintenance (including replacement of parts) has been performed on the instrument. See Special Procedures and Troubleshooting in this manual.
Do the Clean the Baths procedure in Chapter 6 of this manual.
Calibrate only when the ambient temperature is within the systems operating range (20-35 C).
Check that you have a sufficient supply of reagents to complete this procedure.
Perform Startup in Heading 1.1 of this manual.
5-2
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CALIBRATION REPRODUCIBILITY
5.4
REPRODUCIBILITY
The ACT diff 2 analyzer includes a Reproducibility function that automatically performs calculations on the samples you run. Reproducibility is a check to ensure that the instrument measures blood parameters consistently and precisely. After you run the sample N times consecutively, the instrument: r r r Calculates the SD of N results of the sample. Calculates the mean coefficient of variation (%CV) and standard deviation (SD) for the parameters Prints PASS or FAIL message for the reproducibility test.
You can run reproducibility in any of the following modes: r r Whole Blood (Closed Vial or Open Vial) Predilute
It is recommended that you run Reproducibility in the Whole Blood mode using either whole blood or a cell control with a known range of values, such as 4C PLUS cell control. To perform statistics, the instrument requires a minimum of three acceptable samples. If a numeric result is not acceptable, the instrument automatically rejects the result. You can also reject a result by touching the Reject icon. There is a summary screen for Reproducibility. Autoprint, if turned ON, prints a sample report upon completion of each run. Autoprint is not an option for printing the summary report; you must manually select the print summary icon. You can print a summary report beginning with the third sample all the way to the thirty-first sample, if you choose to run that many samples. Note: When doing Reproducibility, Carryover, or Calibration, do not leave the screen until you finish analyzing the required number of samples. Leaving the screen without finishing the required analysis will delete your data, which means that you must restart the test.
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Select a sample that meets these parameter criteria: WBC at 6.0 - 15.0 x 103 cells/L RBC at 3.00 - 6.00 x 106 cells/L Hgb at 12.0 - 18.0 g/dL MCV at 80.0 - 100.0 fL Plt at 200 - 500 x 103 cells/L
At the Main screen, select the desired mode to run normal samples or 4C PLUS cell control.
At the QA screen, touch the Reproducibility icon.
5-4
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Analyze the sample based on the mode you selected in step 2. If a non-numeric result is obtained or if you manually reject the sample, the Trash icon appears in the lower left corner of the screen.
When the sample result is displayed, touch the Trash icon to manually delete the first (prime) sample.
Repeat step 5 until an N of 10 is achieved. Look at the upper left corner of the screen for the N#. After the instrument accepts the data, the Reproducibility results are stored. Note: Up to 31 samples can be run as part of the statistical calculations.
If you are using a graphic printer, touch the Print Summary icon. The Reproducibility Summary Report prints similar to that shown below. Keep a copy for your records. Note: A minimum of two samples is needed to print a sample summary.
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5-5
Note: For information on parameter limits, refer to PERFORMANCE SPECIFICATIONS in the Reference manual. If Reproducibility fails, contact your local Beckman Coulter Representative.
Do Heading 5.5, CARRYOVER.
5-6
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CALIBRATION CARRYOVER
5.5
CARRYOVER
Carryover is a check to make sure that no part of a sample is carried over to the next sample, thus affecting the next samples results. Carryover: r r determines if there is carryover from the sample, and prints PASS or FAIL message for the carryover test.
Note: You may use 4C PLUS cell control as an alternative to normal whole-blood samples. The instrument determines what is acceptable for carryover. When doing Reproducibility, Carryover, or Calibration, do not leave the screen until you finish analyzing the required number of samples. Leaving the screen without finishing the required analysis will delete your data, which means that you must restart the test.
Be sure that you completed Reproducibility.
! !
Touch the Carryover icon.
Place the well-mixed sample into the tube holder, and close the door.
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5-7
Repeat step 3 for the second sample.
Run a blank sample (air) by closing the tube holder.
Repeat step 5 twice for a total of three blank samples.
Touch the Summary icon to view the summary screen. Note: The N# on the screen indicates the numbers of acceptable runs.
5-8
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Touch the Print Summary icon to print a summary report for your records.
This is an example of a Carryover Summary Report. Note: For information on parameter limits, refer to PERFORMANCE SPECIFICATIONS in the Reference manual. If Carryover fails, contact your local Beckman Coulter Representative.
Do Heading 5.6, AUTO-CALIBRATION.
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CALIBRATION AUTO-CALIBRATION
5.6
AUTO-CALIBRATION
Calibration standardizes the instrument by determining its deviation from calibration references and adjusting calibration factors as needed. The S-CAL calibration kit helps you determine whether the calibration factors of the instrument need to be changed. Assigned values are provided in the S-CAL calibration kit package insert. Only the package inserts provided with the S-CAL calibration kit provide the correct assigned values for the calibrator. For automated calibration, you simply cycle the S-CAL calibrator in the Closed Vial Whole Blood mode. After you enter the ASSIGNED VALUES from the S-CAL calibrator package insert, calculations and comparisons to assigned values are done automatically by the instrument. You can save the calibration data. After calibration is completed, a PASSED, NEEDED or FAILED message appears for each parameter. When doing Reproducibility, Carryover, or Calibration, do not leave the screen until you finish analyzing the required number of samples. Leaving the screen without finishing the required analysis will delete your data, which means that you must restart the test.
Be sure that you completed the Reproducibility and Carryover procedures.
! !
Verify that one vial of the S-CAL calibrator is at room temperature.
5-10
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Print the calibration setup report. a. At the Main screen, touch the Setup icon.
b.
At the Setup screen, touch the Setup Report icon.
c.
After the calibration setup report prints, touch the Exit icon.
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5-11
At the QA screen, touch the Calibration icon.
The calibration assay screen appears.
Refer to the TABLE OF ASSIGNED VALUES on the S-CAL calibrator package insert.
S-CALKIT
COULTER Calibrator
TABLE OF ASSIGNED VALUES
On the screen, touch the field where you want to enter values, and enter the values from the TABLE OF ASSIGNED VALUES using the keypad.
1 4 7
2 5 8
3 6 9
. 0
5-12
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Save the values you entered by touching the Continue icon.
The run screen appears. The ID# refers to the number of runs done under this calibration procedure. The N# refers to the actual number of accepted samples for this test.
Mix the S-CAL calibrator according to the package insert.
10 Pipette the S-CAL calibrator into the

empty mixing tube according to the instructions in the package insert.
! !
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11 Place the well-mixed sample in the tube

holder at the Cap Pierce Station and close the door. Note: If the door is inadvertently closed after it has opened automatically, or if it is closed at a screen where samples are not run, you can open the door by touching the Main Menu icon and then the Sample Results icon.
12 When the tube holder opens:

a. b. c. Remove the calibrator vial from the holder. Mix the vial gently between each cycle. After analysis is complete, the results of sample #1 appear.
If an Aperture Alert message or any non-numeric result (XXXXX, - - - - -, , +++++) occurs, the results will be displayed but the instrument automatically rejects them. r If a result is rejected by the instrument, the N# does not increment. If you choose to reject the result for the last sample run, the N# automatically decrements by 1. (You can only reject the last sample analyzed.)
5-14
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13 Repeat steps 11 and 12 for each of the 11

calibration samples. Note: The instrument does not use results for the first replicate. It performs statistics on replicates 2 through 11 for a total of 10. The instrument automatically saves the results.

15 After 11 acceptable sample results, the

Print Summary icon appears; touch the icon
to view the summary screen. r If Autoprint is ON and you are using a graphic printer, a summary report prints automatically. If autoprint is OFF you can print a , report summary by pressing the Print Summary icon.
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5-15
This is an example of a Calibration Summary Report.
7420111A
5-16
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16 Review the status of each result. For

information on parameter limits, refer to PERFORMANCE SPECIFICATIONS in the Reference manual. r If PASSED appears for all the parameters, calibration adjustments are not required. Touch the Return icon. Note: Touching the Return icon does not update the calibration factors.
If NEEDED appears for any of the parameters, calibration adjustments are required. Touch the Save and Exit icon to automatically replace the NEEDED calibration factor with the new calibration factor. This automatically updates the instruments calibration parameters. Print the new calibration factors and place them in your log book. Verify calibration by analyzing one replicate for each level of control.
If FAILED appears, the % diff value and/or CV% exceeds the high acceptable limit. You cannot save FAILED calibration results. Call your local Coulter Service Representative for assistance.
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17 Verify calibration by running 4C PLUS cell

control. See Running COULTER 4C PLUS Cell Control under Heading 2.2, RUNNING CONTROLS for instructions.
5-18
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6 SERVICE AND MAINTENANCE 6

6.1 GENERAL MAINTENANCE
This chapter details the ACT diff 2 analyzer maintenance procedures that are your responsibility. It also includes a troubleshooting guide to help you solve instrument problems. You perform maintenance procedures either on a time schedule or on an instrument cycle schedule. Keep a calendar marked with dates for maintenance and check the Startup results screen for the number of cycles performed.
CAUTION Incorrectly performed maintenance procedures can damage the ACT diff 2 analyzer. Do not attempt any procedures that are not included in this manual or in the instrument replacement cards. Call your Beckman Coulter Representative for service and maintenance beyond the scope of Coulter documentation.
Cycle Counter
The cycle count appears on the Startup results screen and on the Diagnostics screen. The cycle number prints on the Startup report.
f
6.2
MAINTENANCE SCHEDULE
Frequency Daily r r Situation Coming out of Shutdown (you touch the Continue icon on the screen). Automatically occurs when powering up after turning the power off during a cycle or after a power interruption during a cycle.
Table 6.1 Maintenance Schedule Maintenance Procedure Startup
Shutdown
Daily
Automatically occurs when powering on more than 2 hours after the previous sample was run. You run Shutdown to clean the instrument. If you consistently run less than 5 samples per day, you may perform Shutdown every other day. r
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SERVICE AND MAINTENANCE MAINTENANCE SCHEDULE
Table 6.1 Maintenance Schedule (Continued) Maintenance Procedure Clean the baths Frequency When necessary r r r r r r Calibration When necessary or as required by your regulatory agency When defective r r r Increased voteouts. Decreased cell counts. Increased MCV values. Increased clog rate (X flag) Failure to recover control values. Erratic MCV, RBC and WBC counts. After replacing major component parts such as an aperture bath assembly. Situation Before any type of calibration.
Replace check valve
When control values are consistently out of expected assay range. Clogged or lets liquid or air flow both ways.
Replace fuses
When blown
r r
No power. Green power LED is not lit. Instrument is plugged in but does not run.
Replace probe wipe block When defective or plugged.
Fluid drips from probe wipe but vacuum is good and instrument works.
Replace tubing
Every 3 years
When cracked, leaking or has lost resilience.
Replace vacuum isolator chamber
When defective
r r r
When you cannot get it clean. When it is cracked or damaged or creating a vacuum leak. If there is buildup under the top, causing Plt and WBC noise problems. Waste does not drain from the baths and VIC Baths overflow
Replace Waste filter
When defective
r r
Replace reagents
When empty
When instrument reports empty and the container is empty.
6-2
PN 4237495BA
SERVICE AND MAINTENANCE CLEANING PROCEDURES
6.3
CLEANING PROCEDURES
WARNING Risk of biohazard. Utilize appropriate barrier protection when performing these procedures, as the instrument may contain biohazardous material.
These are not routine procedures. Use them only if necessary for troubleshooting or before calibrating.
Zapping the Aperture

Zap the aperture when the instrument: r r r r r r Produces increased Aperture Alerts. Produces increased voteouts. Produces decreased cell counts. Produces increased MCV values. Fails to recover control values. Produces erratic MCV, RBC and WBC counts.
At the Main screen, touch the Diluter Functions icon.
! !
At the Diluter Functions screen, touch the Zap Aperture icon.
PN 4237495BA
6-3
At the Diluter Functions screen, touch the Exit icon.
Cleaning (Bleaching) the Baths

Bleaching removes any clog or debris that restricts proper sample flow. Occasionally, you must do this procedure for troubleshooting.
Fill a tube (from which the ACT diff 2 analyzer can aspirate) with more than 1 mL of high quality, fragrance-free bleach (5% sodium hypochlorite - available chlorine).
! !
At the Main screen, touch the Diluter Functions icon.
6-4
PN 4237495BA
At the Diluter Functions screen, touch the Clean Baths icon.
Present the tube to the probe so that the tip is well into the bleach, and press the aspirate switch.
The instrument cleans the baths.
PN 4237495BA
6-5
The cleaning procedure takes approximately 15 minutes to be completed. Note: If you want to cancel the cleaning procedure before the 15 minute cleaning period ends, touch the Stop icon.
When the procedure is completed, the Diluter Functions screen reappears. Touch the Exit icon to exit the screen.
6-6
PN 4237495BA
Cleaning the Outside of the Instrument
! !
Clean the outside of the instrument with a damp cloth and distilled water. This prevents the buildup of corrosive deposits. Clean up spills promptly. Pay particular attention to the probe wipe housing.
Cleaning the Inside of the Instrument
! !
Clean the inside of the instrument (behind the front door and beneath the bath shield) with a damp cloth and distilled water if obvious evidence of corrosive deposits exists. Be careful not to wipe contaminants into the bath.
Cleaning the Closed Vial Station
If you have a spill or excessive buildup in the Closed Vial Station, do the following procedure immediately.
PN 4237495BA
6-7
Tools/Supplies Needed
I H2
B Paper towels B Bleach solution (9 parts distilled water, 1 part high quality, fragrance-free bleach (5% sodium hypochlorite - available chlorine) B Cotton swabs
Turn off the instrument.
! !
Unplug the instrument from its power source.
6-8
PN 4237495BA
CAUTION Risk of instrument damage. If the instruments front door is opened when the Cap Pierce door is open, the instrument may be damaged. Before opening the instruments front door, verify that the Cap Pierce door is closed.
Open the left door.
Use a regular (flat) screwdriver to turn the fastener that secures the front door.
PN 4237495BA
6-9
Pull the front door open.
Open the tube holder door so that the tube holder is visible.
Place paper towels beneath the Cap Pierce Module.
6-10
PN 4237495BA
Remove the tube holder by pinching the clips together and sliding the holder out of its slot.
Verify that the Cap Pierce Door is free of debris. If necessary, do the Cleaning the Closed Vial Door procedure
10 Wipe off the Cap Pierce Door with the

diluted bleach solution.
PN 4237495BA
6-11
11 Squirt bleach solution into the tube

detector area.
12 Using a cotton swab, wipe off the inside

of the tube detector area.
13 Properly dispose of all cleaning

material.
6-12
PN 4237495BA
14 Replace the tube holder that you

removed in step 8. Be sure to position the opening towards the back of the instrument and to snap the holder into place.
15 Plug instrument into power source.
16 Turn instrument on, and resume

normal operation.
PN 4237495BA
6-13
Cleaning the Closed Vial Door

Tools/Supplies Needed B Bleach solution: 9 parts distilled water, 1 part high quality, fragrance-free bleach (5% sodium hypochlorite - available chlorine)
I H2
! !
Using a cotton swab, clean the inside of the tube holder.
6-14
PN 4237495BA
Plug the instrument into its power source.
Turn the instrument on and resume normal operation.
PN 4237495BA
6-15
Cleaning the Fans Dust Filter

The fan is located on the back panel, and the filter is inside the fans housing.
! !
Remove the grill and filter.
6-16
PN 4237495BA
Clean the filter in water, and dry thoroughly.
Replace the filter and grill.
PN 4237495BA
6-17
SERVICE AND MAINTENANCE CALIBRATION PROCEDURES
6.4 6.5
CALIBRATION PROCEDURES
See Chapter 5, Calibration.
ACT diff 2 ANALYZER COMPONENT LOCATIONS

Inside Front
1 2
15
14
13
12
11
10
1 2 3 4 5 6 7 8
Software Card Slot Horizontal Traverse Motor Closed Vial Sample Handler Motor Closed Vial Sample Handler Vacuum Isolator Chamber Hgb Lamp LV17 WBC Bath
LV16
10 Sweepflow Spool 11 RBC Bath 12 Aspirate Switch: Open Vial and Predilute 13 Probe 14 Probe Wipe Block 15 Horizontal Traverse Assembly
LV17
On = Opens/Off = Closes count path from WBC bath
LV16 On = Opens/Off = Closes count path from RBC bath
6-18
PN 4237495BA
SERVICE AND MAINTENANCE ACT diff 2 ANALYZER COMPONENT LOCATIONS
Inside Right
1 2 3
16
5 15 6 14
13
10
12
11
7515017A
1 2 3 4 5 6 7 8
Sample Pump (50 L) Diluent Pump (100 L) Lyse Pump (100 L) LV9 (Diluent reservoir fill enable) LV10 (Probe wash diluent select) LV11 (WBC/RBC bath diluent select) LV12 (WBC bath drain enable) Vacuum Adjust Knob
LV18 (Waste/Rinse select)
10 Diluent Reservoir 11 Diluent Reservoir Pump 12 Waste/Rinse Pump 13 Rinse Pump 14 LV7 (VIC drain enable) 15 LV15 (RBC bath drain enable) 16 LV8 (Probe wipe waste enable)
PN 4237495BA
6-19
SERVICE AND MAINTENANCE REPLACEMENT PROCEDURES
6.6
REPLACEMENT PROCEDURES
Replacing Reagents
For information on connecting the reagents the first time, see the Installation and Training Guide. A change of reagents may be necessary when you see one of these symbols:
Replacing the diff ACT Pak Reagent Periodically check the expiration date on the reagent container. Do not use an expired reagent. Replace the reagent if the existing reagent is expired or empty.
Be sure your reagent is the diff ACT Pak reagent. Note: If you have the diff ACT Tainer reagent, do the Replacing the diff ACT Tainer Reagent procedure.
6-20
PN 4237495BA
Check to see if the reagent container is empty. r If the container is not empty, touch one of the Reagent icons or the Reagent Management Card icon on the screen to prime. If the container is not empty but the Reagent Management Card icon continues to appear, reinsert the reagent card. If the problem persists, go to step 3. r If the container is empty, go to step 3. or
or
Remove the diff ACT Pak reagent management card from the instrument. Note: Keep the card for use with IQAP if your laboratory is a participant in the IQAP program.
Get a new diff ACT Pak reagent container.
PN 4237495BA
6-21
Pull the perforated cardboard from the reagent container box, and remove the management card.
rd nt Ca me nage Ma
At the front of the instrument, insert the management card from the reagent container into the slot, with the contact area facing the touch screen.
Management Card
Place the new reagent container on the floor next to the empty container.
< 81.08 cm
6-22
PN 4237495BA
Remove the cap and seal for tube number 1.
IMPORTANT Risk of misleading results if the pickup tubes are contaminated. Ensure that the reagent pickup tubes remain clean and free of contamination.
Remove reagent pickup tube 1 from the empty reagent container.
PN 4237495BA
6-23
10 Insert reagent pickup tube 1 into the

new container and tighten the cap.
1
11 Repeat steps 9 and 10 for reagent

pickup tube 2.
2
12 Touch the Lyse Prime icon, if displayed.
6-24
PN 4237495BA
13 Touch the Diluent Prime icon, if

displayed.
14 In your laboratory log book, record the

reagent lot number and expiration date from the new diff ACT Pak reagent.
Replacing the diff ACT Tainer Reagent Change the reagent container when you see one of these symbols
Be sure your reagent is the diff ACT Tainer reagent. If you have the diff ACT Pak reagent, do the Replacing the diff ACT Pak Reagent procedure.
PN 4237495BA
6-25
Check to see if the reagent container is empty. r If the container is not empty, touch the Reagent icon or the Reagent Management Card icon on the screen to prime. If the container is not empty but the Reagent Management Card icon continues to appear, reinsert the reagent card. If the problem persists, go to step 3. r If the container is empty, go to step 3. or
or
Remove the diff ACT Tainer reagent management card from the instrument. Note: Keep the card for use with IQAP if your laboratory is a participant in the Coulters IQAP program.
Get a new diff ACT Tainer reagent container.
6-26
PN 4237495BA
Remove the new reagent management card from the sleeve on the reagent container.
C nt me ge na Ma
ard
Insert the diff ACT Tainer reagent management card from the new reagent container into the slot at the front of the instrument. Be sure the contact area is facing the touch screen.
Management Card
Unscrew the three white plastic caps from the container.
Remove the seals to expose each opening.
PN 4237495BA
6-27
Open the reagent compartment door and remove the empty diff ACT Tainer reagent.
10 Remove the pickup tubes from the

reagent container: a. b. Unscrew the caps. Pull the reagent tubes from the container.
6-28
PN 4237495BA
11 Connect pickup tubes 1, 2, and 3 to the

new reagent container box: a. Insert the cap end of pickup tube 1 into opening 1 of the reagent container. Screw the cap to the container. Insert the cap end of pickup tube 2 into opening 2 of the reagent container. Screw the cap to the container. Insert the cap end of pickup tube 3 into opening 3 of the reagent container. Screw the cap to the container.
1
b. c.
d. e.
f.
12 Place the container, with tubes

attached, in the reagent compartment.
PN 4237495BA
6-29
13 Close the reagent compartment door.
14 Touch the Lyse Prime icon, if displayed.
15 Touch the Diluent Prime icon, if

displayed.
16 In your laboratory log book, record the

reagent lot number and expiration date from the new diff ACT Tainer reagent.
6-30
PN 4237495BA
Replacing the AC T Rinse Shutdown Diluent Replace the diluent when you see this screen:
Check to see if the ACT Rinse shutdown diluent container is empty. r r If it is not empty, touch the Continue icon to prime the rinse lines. If it is empty, go to step 2.
Open the reagent compartment door and remove the rinse container (with tubing still attached.)
Remove pickup tube from the rinse container: a. b. Unscrew the cap. Pull the tube from the container.
PN 4237495BA
6-31
Connect pickup tubes to the new diluent container: a. b. Insert the cap end of pickup tube into the rinse container. Screw the cap to the box.
Place the new rinse container into the reagent management compartment and close the door.
Touch the Continue icon.
6-32
PN 4237495BA
Replacing the Waste Container

Replace the waste container when you see either of these screens:
WARNING Risk of biohazard. Waste can include biohazardous material that could cause contamination. Handle and dispose of according to acceptable laboratory standards. Risk of biohazard if instrument is operated when the waste level sensor is disconnected. Prevent the biohazard by operating the instrument when the waste level sensor is connected.
Remove the tubing from the full waste container.
Insert the tubing into the new waste container, securing the cap by turning clockwise.
PN 4237495BA
6-33
Touch the Continue icon.
Place a cap on the full waste container and dispose of properly.
Replacing the Vacuum Fluid Barrier 1

Turn the instrument off.
! !
6-34
PN 4237495BA
Open the right compartment door.
Locate the vacuum fluid barrier.
PN 4237495BA
6-35
Remove the vacuum fluid barrier from the tubing: a. Twist off the top connector.
b.
Twist the fluid barrier off the bottom connector.
Properly dispose of used fluid barrier.
Connect a new fluid barrier to the tubing by inserting tubing end into filter and turning the connector until secure.
6-36
PN 4237495BA
Repeat step 7 to connect the other end of the fluid barrier.
Close the right door.
10 Plug the instrument into its power

source.
11 Turn the instrument on and resume

normal operation.
PN 4237495BA
6-37
12 Cycle a sample with known results to

verify instrument performance. Note: If a vacuum error appears, adjust the vacuum. See the Adjusting the Vacuum procedure.
Replacing Check Valves

Check valves allow liquid or air to flow through in one direction only. Replace a check valve if: r r It is clogged. It lets liquid or air flow both ways.
A regular, flathead screwdriver is needed for this procedure.
At the main menu screen, touch the Diluter Functions icon.
6-38
PN 4237495BA
If you are replacing a check valve connected to the bottom of the counting baths, touch the Drain Baths icon at the Diluter Functions screen.
! !
If you are replacing a check valve not connected to the counting baths, go to step 3.
! !
If you are replacing a check valve not connected to the counting baths, go to step 6.
Open the appropriate compartment door.
PN 4237495BA
6-39
Remove the bath shield/cover.
CAUTION Risk of instrument damage and/or misleading results if the check valve is inserted in the wrong orientation. Be sure to orient (point) the new check valve in the same direction as the old one.
Note the direction that the check valve is pointing before you remove it.
WARNING Biohazardous material might be contained in the check valves and associated tubing and could cause contamination unless handled with care. Wear protective gear. Avoid skin contact. Clean up spills immediately. Dispose of valve and tubing according to acceptable laboratory procedures for biohazardous materials.
Use a screwdriver to pry the tubing from the top of the check valve.
6-40
PN 4237495BA
Connect the tubing to the top of the new check valve.
Use a screwdriver to pry the tubing from the bottom of the old check valve.
10 Connect the tubing to the bottom of the

new check valve. Be sure you properly orient the replacement valve.
11 Properly dispose of used check valve.
PN 4237495BA
6-41
12 If you replaced a check valve that was

connected to one of the counting baths in the front of the instrument, replace the metal cover. If you did not replace a check valve that was connected to one of the counting baths, go to step 13.

normal operation.

verify instrument performance. Watch the sample and ensure that the check valve is working properly and does not leak.
15 After you verify that the check valve is not

leaking, close all instrument doors and resume normal operation.
6-42
PN 4237495BA
Replacing Tubing
Replace tubing if it is cracked, leaking or has lost resilience. Scissors are needed for this procedure.
At the main menu screen, touch the Diluter Functions icon.
! !
At the Diluter Functions screen, touch the Drain Baths icon.
! !
Remove the tubing section from the two components it connects.
PN 4237495BA
6-43
Measure the new tubing of the same material, color code and bore size of the old tubing you just removed.
Cut the new tubing with scissors at the desired length.
Push new tubing onto the two components it is to connect.
At the Main screen, touch the Startup icon.
10 Run a sample with known results to

verify instrument performance. Note: Make sure that the new tubing is correctly connected and does not leak.
6-44
PN 4237495BA
Replacing Fuses
Replace fuses as needed. A regular, flathead screwdriver is needed for this procedure.
2.5 Amp Slo Blo 250V
ON OFF
F1
F2
AC
J1 INPUT ELECTRICAL POWER SUPPLY AC INPUTS 90 - 132v / 198 - 264v
FUSE 3AG 1 . 5A 250V WARNING TO AVOID ELECTRIC CONNECT ONLY SHOCK DISCONNECT TO A PROPERLY POWER CORD PRIOR TO EARTH GROUNDED REMOVING OR REPLACING OUTLET . FUSE . REPLACE FUSE ONLY WITH THE TYPE AND RATING SPECIFIED .
! !
PN 4237495BA
6-45
Unscrew the fuse holder from the back of the instrument, where F1 is marked.
Remove the fuse from the holder.
Insert the new fuse into the holder.
Screw the fuse holder back into the instrument at F1.
6-46
PN 4237495BA
Plug the power cord back into the instrument at AC INPUT.
PN 4237495BA
6-47
Replacing the Vacuum Isolator Chamber (VIC)

Replace the Vacuum Isolator Chamber (VIC) when it is defective. See Table 6.1 for defective situations. Needle-nose pliers are needed for this procedure.
! !
6-48
PN 4237495BA
Open the front door of the instrument: a. Open the left side door.
b.
Use a regular (flat) screwdriver to loosen the screw that secures the front door.
c.
Pull open the front door.
PN 4237495BA
6-49
WARNING The waste pump tubing can contain biohazardous material that could cause contamination if not handled properly. Handle these components according to acceptable laboratory practices.
Remove the metal cover and locate the VIC.
Remove the numbered tubing from the top of the VIC. Note: If any tubing to the VIC is worn or cracked, replace it with new tubing from your accessory kit. See the Replacing Tubing procedure for instructions.
Remove the tubing from the bottom of the VIC.
6-50
PN 4237495BA
Slide the VIC up out of the tie wrap. Note: If necessary, you can open the tie wrap or cut and replace it.
Properly dispose of the used VIC.
Insert the new VIC into the tie wrap with port 4 facing the front of the instrument. (Tighten the tie wrap if necessary.)
PN 4237495BA
6-51
10 Connect the tubing to the bottom of

the new VIC.
11 Connect tubing LV17 to fitting number

2 on the VIC, feeding the tubing as shown.
2
LV17
12 Connect the tubing from Y fitting

number 5 and number 6 on the VIC. Note: The tubing and the VIC fittings are not numbered the same due to the quantity of fittings throughout the entire instrument.
6 5
6-52
PN 4237495BA
13 Connect tubing to fitting number 3 on

the VIC.
14 Connect tubing from LV16 to fitting

number 4 on the VIC.
4
LV16
15 Replace the metal cover and secure.
PN 4237495BA
6-53
16 Close the front door.

source.

normal operation.
19 Do the Adjusting the Vacuum

procedure.
6-54
PN 4237495BA
Adjusting the Vacuum
At the Main screen, touch the Diagnostics icon.
At the Diagnostics screen, touch the Voltages/Sensors icon.
Locate the vacuum setting indicator.
Open the right door and locate the vacuum adjustment knob.
PN 4237495BA
6-55
Turn the knob to adjust the setting to 6.00 in/hg.
Cycle a sample with known results to verify instruments performance.
6-56
PN 4237495BA
Replacing the Probe Wipe

Replace the probe wipe when it is defective or plugged. If fluid drips from the probe wipe but vacuum is good and the instrument works, then the probe wipe is probably defective and you should replace it. Do not attempt to run the instrument if the probe is bent or loose.
.
! !
PN 4237495BA
6-57
Open the left side door.
6-58
PN 4237495BA
Slide the probe assembly to the left.
WARNING To avoid being exposed to biohazardous material, adhere to standard laboratory safety procedures.
Pull the aspiration probe up into the probe assembly.
Remove the metal clip that holds the probe wipe in the probe assembly.
PN 4237495BA
6-59
Remove the probe wipe from the assembly: a. b. Using your left hand, grasp the vertical bar. Push the probe down to dislodge the probe wipe.
c.
Remove the probe wipe from the housing.
10 Disconnect the tubing from the probe

wipe.
6-60
PN 4237495BA
11 Properly dispose of the probe wipe.
12 Connect the tubing to the new probe

wipe: a. b. Connect the narrow tubing, number 4, to the top fitting. Connect the wide tubing, number 5, to the bottom fitting.
13 Insert the probe wipe into the assembly,

with the groove at the top of the wipe.
PN 4237495BA
6-61
14 Slide the clip into the groove of the

probe assembly to secure the probe wipe.
15 Push the probe all the way down until

it is fully descended.
6-62
PN 4237495BA

source.

normal operation.

verify instruments performance.
PN 4237495BA
6-63
Replacing the Tube Holder

Tools/Supplies Needed B Regular (flat) screwdriver
! !
Open the left door.
6-64
PN 4237495BA
Locate the tube holder.
PN 4237495BA
6-65
Open the tube holder door so that the tube holder is visible.
Pinch the clips together and slide the tube holder out of its slot.
Properly dispose of the tube holder.
6-66
PN 4237495BA
10 Insert the new tube holder:

a. b. Be sure the opening is towards the back of the instrument. Snap the tube holder in place.
11 Close the tube holder door.

source.
PN 4237495BA
6-67

normal operation.
Replacing the Waste Filter
Tools/Supplies Needed B Waste filter B Pliers
! !
6-68
PN 4237495BA
Remove the waste filter.

18
18
Properly dispose of the used waste filter.
PN 4237495BA
6-69
Install the new waste filter.
18
6-70
PN 4237495BA
SERVICE AND MAINTENANCE PREPARING TO SHIP THE INSTRUMENT
6.7
PREPARING TO SHIP THE INSTRUMENT

When you have done all the troubleshooting and still cannot fix the problem, call your Beckman Coulter Representative. If directed to, follow the authorization procedures and prepare the instrument for shipment as follows. Two containers, bleach, distilled water, and paper towels are needed for this procedure.
I H2
CAUTION Risk of instrument damage. If the instrument remains dormant for extended periods of time without the appropriate Startup, Shutdown, or Prepare to Ship functions being performed, the fluid metering pumps may dry out and become damaged. When preparing the instrument for shipping, you must carefully follow all recommended procedures for Startup and Shutdown as noted in the following procedure.
At the Main screen, touch the Diagnostics icon.
! !
At the Diagnostics screen, touch the Prepare to Ship icon.
PN 4237495BA
6-71
WARNING Instrument tubing can contain biohazardous material that can cause contamination if not handled properly. Handle these components according to acceptable laboratory practices.
Remove the diluent and lytic reagent pickup tubes from the reagent containers. r For diff ACT Pak reagent, remove both pickup tubes
For diff ACT Tainer reagent, remove all three pickup tubes
Remove the pickup tubes from the ACT Rinse shutdown diluent container, if using the diff ACT Pak reagent.
Touch the 1 to continue. This process takes approximately 2 minutes.
6-72
PN 4237495BA
Place the diluent and lytic reagent tubes upright in a deep container filled with distilled water.
I H2
Place the rinse tube upright in a deep container filled with a 50% bleach-50% distilled water solution.
50% DISTILLED WATER 50% BLEACH
Touch the 2 to continue. This process takes approximately 15 minutes.
PN 4237495BA
6-73
Remove the ACT Rinse shutdown diluent pickup tube from the bleach and place it with the others in distilled water.
10 Touch the 3 to continue.

This process takes approximately 2 minutes.
11 Remove the tubes from their respective

solutions and place them on a paper towel to dry.
12 Touch the 4 to continue.

This process takes approximately 4 minutes, 15 seconds.
6-74
PN 4237495BA
13 When the Ready to Ship screen

appears, the instrument is cleaned out and decontaminated.
14 Turn the instrument off.
15 Prepare to decontaminate the waste

tubes and sensor: a. b. Remove the waste tubes and sensor from the waste container. Squirt the waste tubes with a bleach solution to decontaminate.
16 Disconnect the reagent and rinse

pickup tubes from the instrument and pack them with the instrument.
17 Tightly seal all reagent containers.
18 Remove the reagent management card

from instrument and put back into the card slot on the reagent container box.
PN 4237495BA
6-75
19 Disconnect all cables (power, printer)

from the instrument. Pack them with the instrument.
20 Pack the instrument in its original box.
21 Ship the instrument to the address

obtained from your Beckman Coulter Representative.
6-76
PN 4237495BA
SERVICE AND MAINTENANCE TROUBLESHOOTING
6.8
TROUBLESHOOTING
Troubleshooting Tools
Knowing what your ACT diff 2 analyzer does, how it sounds when operating properly, and what normal results look like are the keys to troubleshooting problems. Study the Normal Sample Flow. Then watch and listen while the instrument goes through its cycles. If you later find that your ACT diff 2 analyzer is not operating properly, you can begin to isolate the problem by studying irregular results (Table 6.10) and watching the instrument cycle a sample.
Diluter Functions
The Diluter Functions screen provides you with basic diluter functions to use in troubleshooting. Table 6.2 describes the diluter functions
.
Table 6.2 Diluter Functions Screen Icon Wet Prime Description Function Primes the diluent fluidic path and baths. Dispenses lytic reagent to WBC bath. Removes air from diluent and lytic reagent lines. Primes the fluidic path from the diluent reservoir through the sweepflow coil and the path between the RBC aperture and the vacuum isolator chamber. Cleans the baths with a solution other than COULTER ACT Rinse cleaning agent (see Cleaning (Bleaching) the Baths). If the zap aperture function does not work, this is the third attempt (after Shutdown) to clear a clogged aperture. Primes the lytic reagent path of the fluidics system. Fills the lytic reagent path completely even if it is empty.
Sweepflow
Automatically drains the baths then, after you aspirate bleach, cleans the baths. Primes the lytic reagent system when the ACT diff analyzer is first installed or reinstalled after being drained. Primes the diluent system.
Primes pickup tube and diluent reservoir. Fills the diluent path (between the diluent container and the diluent reservoir) completely, even if it is empty.
PN 4237495BA
6-77
Table 6.2 Diluter Functions Screen (Continued) Icon Description Drains the baths and the vacuum isolator chamber. Primes the diluent reservoir system and fills both baths with fresh diluent. Function Drains fluid before you remove the baths or the vacuum isolator chamber. Verifies the operation of the waste pump. Verifies operation of the rinse pump. Helps detect a plugged filter. Checks the operation of the diluent pump if you use it enough times to force a refill of the reservoir. Verifies operation of air/mix system. Helps detect plugs or leaks in the fluid barrier. Attempts to clear a plugged aperture, perform several times.
Sends mixing bubbles to each bath in turn. Performs an aperture burn or zap. Dispenses lytic reagent into the WBC bath. Exits from the Diluter Functions screen.
Manually primes the lytic reagent system. Checks for bubbles in the lytic reagent system. Verifies the operation of the lytic reagent pump. Returns to previous screen.
Diagnostic Functions
The Diagnostic Functions screen provides you with basic diagnostic functions to use in troubleshooting. Table 6.3 describes the diagnostic functions.
.
6-78
PN 4237495BA
Table 6.3 Diagnostic Functions Screen Icon Description Displays current state of digital sensors and current value of analog sensors and voltages. Displays solenoids screen and allows you to change the state (ON or OFF) of each solenoid and DC motors. Displays verify predilute screen. Displays details of the last sample run screen. Displays motors screen and allows you to interactively run each motor through its normal range of motion. Displays an in-progress screen and performs an electronics pulse test. Latex gain Calibration Prepare the instrument for shipping. Exits the Diagnostic Functions screen. Function Lets you adjust to 6.00 vacuum. Lets you verify correct sensor readings.
Lets you test solenoid functions and DC motors. Indiscriminate use of these functions can damage the instrument. Do not use the motors function without instruction from your Beckman Coulter Representative. Lets you verify that the instrument is dispensing 4000 L of diluent. Creates prediluted sample. Lets you troubleshoot aperture problems. Indiscriminate use of these functions can damage the instrument. Do not use the motors function without instruction from your Beckman Coulter Representative.
Lets you verify the electronic stability of the instrument for WBC and RBC apertures. Lets you set particle sizes for WBC, RBC, and Plt gains.
Lets you drain and disinfect the instrument in preparation for shipping. Returns to previous screen.
PN 4237495BA
6-79
SERVICE AND MAINTENANCE PARAMETER CODES AND FLAGS
6.9
PARAMETER CODES AND FLAGS

Analyze samples within 24 hours of collection. Report results immediately if there are no flags and if the results are within your reference ranges. Table 6.4 shows the parameter codes and flags that can appear with results. Also note: r r If any flag appears, review the results according to your laboratorys protocol. The cells of whole blood collected in EDTA undergo a process of equilibration. White blood cells of certain samples might take up to 30 minutes to reach this state of equilibration in the EDTA. Also, after 5 hours, cellular deterioration might start to occur. These samples might show increased flagging of differential parameters (1, 2, 3, M). If a sample that produces differential flags is less than 30 minutes old, reanalysis of the sample at a later time might eliminate the differential flags.
Whole blood samples processed between 30 minutes and 5 hours of collection provide the best differential performance for all sample types, collection devices, and collection variables. Prediluted samples processed between 5 minutes and 1 hour of collection provide the best differential performance for all sample types, collection devices, and collection variables.
Hierarchy of Flags
There are two types of flags: r r Those that replace the parameter results, also known as codes, and Those that appear next to the parameter results. Up to two of these flags can be displayed for a parameter.
Replacement Flags (Codes) For those flags that replace the parameter results, the hierarchy, in decreasing order of importance, is:
----+++++
XXXXX .....
Non-Replacement Flags For those flags that appear next to the parameter results, the hierarchy, in decreasing order of importance, is:
X + * 1, 2, 3, 4, M (where M means multiple regions) H or L
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SERVICE AND MAINTENANCE WHAT FLAGS AND CODES MEAN
6.10 WHAT FLAGS AND CODES MEAN

Table 6.4 describes the flags and suggests actions you should perform when they appear.
Table 6.4 What Flags Mean Flag/Code Indication Total Voteout. Replaces result when: r r Two of the three count periods did not agree. For WBC and RBC, the first count period votes out. 1. 2. Suggested Action Thoroughly mix and rerun the sample. If the voteout repeats, zap apertures: a.
----(dashes)
You also see . . . . . for any parameter derived from a parameter replaced by - - - - -. If for WBC, also - - - - - for LY#, MO#, GR#, LY%, and * for MO%, and GR%. If for RBC, also . . . . . for Hct, MCH and MCHC, and * for MCV, RDW, Plt, MPV, (Pct and PDW). If for MCV, also . . . . . for Hct and MCHC, and * for RDW. If for Plt, also .
b.
. . . . for MPV (Pct and PDW).
c.
If for MPV, also * for Plt (Pct and PDW). If for PDW, also * for Plt, MPV (and Pct).
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Table 6.4 What Flags Mean (Continued) Flag/Code Indication d. Suggested Action
----(continued)
e.
3. 4. 5.
Thoroughly mix and rerun the sample. If the voteout repeats, run a previously run sample with known values. If the voteout repeats, clean the baths according to Cleaning (Bleaching) the Baths in this chapter. Thoroughly mix and rerun the sample. If the voteout repeats, call your Beckman Coulter Representative.
6. 7.
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Table 6.4 What Flags Mean (Continued) Flag/Code Indication Results exceed operating range. r If for Plt, also . . . . . for MPV (Pct and PDW), and * for WBC, LY#, MO#, GR#, Hgb, MCH, MCHC. If for Hgb, also . . . . . for MCH and MCHC. If for RBC, * for MCV, RDW, Plt, MPV (Pct and PDW) and Hct; also . . . . . for MCH and MCHC. If for WBC, also . . . . . for LY%, MO%, GR%, LY#, MO#, GR#; also * for RBC, Hgb, Hct, MCV, MCH, MCHC, RDW, Plt, and MPV (Pct and PDW). Suggested Action For WBC, RBC, Hgb or Plt (if high sample result is possible: 1. 2. Ensure that the bath shield is in place. Make a dilution to determine the parameter result: a. Dilute 1 part thoroughly mixed sample with 1 part normal saline (0.85% NaCl) in a clean test tube. Mix then immediately run the dilution in whole blood mode. Multiply the parameter result by 2. Corrected result = (Dilution result x 2) Correct derived parameters if applicable. If result still gives +++++, increase dilution and repeat.
+++++
(pluses)
r r
b. c.
d. e.
If you suspect an instrument problem, run a sample or control with known results to determine the instrument problem: 1. 2. 3. Verify probe wash. Verify lyse levels and delivery. Verify diluent levels and delivery.
+++++
MCV <50 fL or >130 fL.
If for MCV <50, also * for RBC, MCH, RDW, Plt, MPV (Pct and PDW); also . Hct and MCHC.
For MCV, verify results by alternative method, such as blood film review or spun Hct.
. . . . for
r
XXXXX
If for MCV >130, also * for RBC, MCH, RDW; also .
. . . . for Hct and MCHC.

1. Remove the stopper and gently mix the sample with a wooden applicator stick to check for fibrin strands or clots: r If fibrin strands or clots are found, collect and run a new sample. If fibrin strands or clots are not found, thoroughly mix and rerun the sample.
Aperture Alert. A problem was detected during counting that could compromise the integrity of the results. r r If on WBC aperture, WBC and differential % and # show XXXXX. If on RBC aperture, RBC, Hct, MCV, MCH, MCHC, RDW, Plt, MPV (Pct and PDW) show XXXXX.
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Table 6.4 What Flags Mean (Continued) Flag/Code XXXXX (continued) Indication 2. 3. Suggested Action If the Aperture Alert repeats, run a previously run sample with known values. If the Aperture Alert repeats, zap apertures: a.
b.
c.
d.
e.
4.
Thoroughly mix and rerun the sample.
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Table 6.4 What Flags Mean (Continued) Flag/Code XXXXX (continued) Indication 5. Suggested Action If the Aperture Alert repeats, clean the baths according to the Cleaning (Bleaching) the Baths procedure in this chapter. Thoroughly mix and rerun the sample. If the Aperture Alert repeats for a specific sample, use an alternative method. If the Aperture Alert repeats for a specific sample, call your Beckman Coulter Representative.
6. 7. 8.
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Table 6.4 What Flags Mean (Continued) Flag/Code Indication Incomplete calculation. Result cannot be calculated. System does not have enough information to compute a result. Parameter derived from parameter with a voteout (- - - - -). If for Hgb, error was detected during Hgb measurement, also . . . . . for MCH and MCHC. The Hgb Blank and/or Hgb Read results do not correlate. See instructions for voteout (1. 2. Suggested Action
.....
(dots)
- - - -).
Thoroughly mix and rerun the sample. If Hgb . . . . . repeats, call your Beckman Coulter Representative. Verify that Hgb lamp is illuminated. r r If not, call your Beckman Coulter Representative. If it is illuminated, run startup to set Hgb lamp voltage.
If on all samples: 1.
2. 3. If for Diff parameters: a. b. c. WBC <1.0 or >99.9 x 103/uL, WBC voteout (Diff # parameters only), or Result cannot be calculated. If c): 1. 2. If a): 1. 2.
If problem persists, call your Beckman Coulter Representative. If Hgb . . . . . repeats, call your Beckman Coulter Representative.
Confirm results. Do manual differential.
If b), see instructions for voteout (- - - - -).
Verify sample handling. If this sample has been refrigerated, warm to room temperature then thoroughly mix and rerun sample. Some samples require a longer than normal equilibration time. Wait 10 to 15 minutes, then thoroughly mix and rerun the sample. If this sample is more than 5 hours old, collect a fresh sample or perform manual differential.
3.
4.
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Table 6.4 What Flags Mean (Continued) Flag/Code Indication If for Hct, MCH and MCHC: Suggested Action If a), see instructions for voteout (- - - - -). If b), see instructions for over operating range (+++++). If c), see Hgb above.
.....
(dots) (continued)
a.
b. c. a. b.
RBC voteout (-
- - - -), or
RBC, Hgb, or MCV > Operating range (+++++), Hgb incomplete (error). Plt voteout. Plt over operating range.
If for MPV (Pct and PDW): If a), see instructions for voteout (- - - - -). If b), see instructions for over operating range (+++++). See instructions for voteout (-
If for Hct and MCHC, MCV voteout.
- - - -).
+
(plus)
Overrange result. Indicates result is greater than linear range but less than operating range: WBC >99.9 <150 x 103/uL RBC >7.00 <8.00 x106/uL Hgb >25.0 <30.0 g/dL Plt >999 < 3000 x 103/uL If for WBC, also * for RBC, Hgb, MCV, Hct, MCH, MCHC, RDW, Plt, MPV (Pct and PDW), and . . . . . for LY#, MO#, GR#, LY%, MO%, and GR%. If for RBC, also * for Hct, MCH MCHC, MCV, RDW, Plt, MPV, (Pct and PDW). If for Plt, also * for MPV (Pct and PDW), WBC, LY#, MO#, GR#, Hgb, MCH, MCHC. If for Hgb, also * for MCH and MCHC.
Verify results according to your laboratorys protocol. If any parameter is outside linearity limits, cycle diluent blank before proceeding with subsequent samples.
1, 2, 3, 4, M
Differential parameters failed the internal regional size distributional criteria at one specific region (1, 2, 3 or 4) or multiple regions (M).
RELATIVE NUMBER
Verify results according to your laboratorys protocol.
LY
MO
GR
1 30 fL 35 fL
2 90 fL
3 160 fL SIZE IN fL
4 450 fL
High result. For Patient samples, result is higher than the high patient sample limit. For Control samples, result is higher than the upper limit for that control sample.
Follow your laboratorys protocol.
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Table 6.4 What Flags Mean (Continued) Flag/Code L Indication Low result. For Patient samples, result is lower than the low patient sample limit. For Control samples, result is lower than the low limit for that control sample. Review results. X flag indicates that one of the multiple Aperture Alert criteria was not met. Suggested Action Follow your laboratorys protocol.
1. 2. 3. 4.
Thoroughly mix and rerun the sample. If flag does not repeat, report result. If flag repeats, clean the aperture as instructed in Zapping the Aperture. If after cleaning, problem persists, contact your Beckman Coulter Representative.
* occurs on parameters influenced by +++++, +, - - - - - as detailed above.

If (Hgb g/dL x 3)/Hct% is <0.8 or >1.2 then RBC, Hgb, MCV, Hct, MCH, MCHC, Plt, MPV (Pct and PDW) are flagged with *. Possible sample handling problem. If on RDW only, RBC histogram failed internal asymmetry check. Possible dual RBC population. If on WBC and Differential only, 35 fL count interference check failed. Possible interference with WBC count. If on Plt, MPV (Pct and PDW) only, Plt <20 x103/uL, or Platelet distribution failure Non-positive curve Mode <3 or >15 fL PDW >20 Voteout of fitted curve Sweepflow error If MCHC <25.0 or >40.0 g/dL, then RBC Hgb, Hct, MCH, MCHC are flagged with *. Possible sample interference or instrument problem.
See instructions for +++++, +, or - - - - - .
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SERVICE AND MAINTENANCE WHAT WARNING MESSAGES MEAN
6.11 WHAT WARNING MESSAGES MEAN

Table 6.5 describes the warning messages and suggested recovery action.
Table 6.5 Warning Messages Warning Description Printer is disconnected. Printer is not turned on. Printer is offline or out of paper. Transmission incomplete Suggested Action Turn printer on and touch printer icon on the Sample Results screen to print. If you have no printer, check to see that auto-print is turned off (Print Profiles screen). See Setting Autoprint in Chapter 2.
Sample transmission to host failed. Touch the transmission icon on the Sample Results screen to retry the transmission. If transmission still fails, check communications cable to host and make sure that the host is online. Check that transmission settings are correct. If failure still occurs, power instrument off and then on. Note: You lose the ability to transmit a sample result when you power off the instrument. Go to voltage screen and try to adjust vacuum to 6.00. If it does not adjust: Make sure the pump is ON. Is there a leak associated with the Vacuum Isolator Chamber and associated tubing? Check all green striped tubing, front and right side. Is tubing connected tightly? Are there leaks? Is fluid barrier filter plugged? If yes, replace fluid barrier and adjust vacuum. Run a startup. Startup tries to adjust Hgb voltage. If it does not adjust: Make sure Hgb lamp is ON. Check for spillage around Hgb components on WBC bath. Make sure there is no diluent leak. (The baths fill.) Proper fluid level must be in the WBC bath at all times. Plt channel overrange. Acknowledge warning; instrument provides numeric results. Verify the results. Check for proper sweepflow operation with no bubbles. Check for sources of electrical interference. Check to ensure that bath shield is on. Check to ensure that Vacuum Isolator Chamber is clean and dry where the count drops appear. Reset the time and date. See Installing the Instrument in Chapter 2.
Vacuum failure
Hgb voltage failure
High Plt count
Time keeper failure
Setup data corrupted
Check the setup values against your records. Correct the values, if necessary, and save. (See Customize Software in Chapter 2.) Print setup values. Run sample. Note: If data is corrupt on powerup, the data will be rewritten with the default data. Be sure to verify setup after this warning is displayed.
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SERVICE AND MAINTENANCE WHAT WARNING MESSAGES MEAN
Table 6.5 Warning Messages (Continued) Warning Description Control file full Suggested Action There is no more storage space available for your 4C PLUS control files. If your laboratory is an IQAP participant, save the control data to a depleted reagent management card. See Heading 2.4, DOWNLOADING 4C PLUS CELL CONTROL RESULTS FOR IQAP. To make room for additional control file storage, you may want to delete some existing control files. See Heading 2.5, DELETING 4C PLUS CELL CONTROL FILES. Do not use this control; it has expired. Use a control that is not expired.
Control expired
Patient data or control data corrupted Check ACT diff Reagent Management card
If this appears during startup, print what is currently stored to determine what patient data, if any, are present. Depending on the type of error, one or possibly all patient samples previously stored may be gone. Make sure card is in reader correctly. If problem persists, it may be time for new reagent with a new card. If problem occurs with a new card, there could be a problem with the card, card reader, card reader connection, or card reader controller (which is part of the display assembly). Do Replacing the Waste Container. Touch the Continue icon.
Waste full
Diluent empty
If reagent container does not appear empty, try priming first. If there appears to be reagent, but it does not fill properly, check for proper position of pickup tube, air leaks in tubing from cube to reservoir. Also check for crimps or plugs in the tubing from the reagent pickup to the bottom of the reservoir. These could affect reservoir fill. If reservoir is overfilled, replace diluent filters. If reagent container does not appear empty, try priming first. If there is lytic reagent in the lytic reagent container, make sure reagent pickup tubing is in fluid and that tubing and fittings are not leaking between reagent pickup and lytic reagent sensor. The lytic reagent sensor is located in the lytic reagent tubing. If the cleaner container does not appear empty, try priming first. If priming does not work, make sure there are no leaks in any blue stripe tubing, beginning at the cleaning reagent pickup. Check the tubing connections to PM1, the tubing to LV18 and the tubing connections to the cleaning agent fluid sensor FS3.
Lytic reagent empty
ACT Rinse Shutdown Diluent (cleaner) empty
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SERVICE AND MAINTENANCE SYSTEM ERRORS
6.12 SYSTEM ERRORS

Turn OFF the instrument, then turn it ON to see if the error is corrected. Table 6.6 offers some suggested actions. If these do not solve the problem, call your Beckman Coulter Representative.
Table 6.6 System Errors
Number 1
Description PCMCIA Error
Probable Cause/Suggested Action Turn instrument OFF. Remove and reinstall software card. Turn instrument ON. If problem still exists, obtain new software card. If problem persists, call your Beckman Coulter Representative. There is an instrument power supply failure or the power to the instrument is out of range. A temporary loss of power can also trigger the error. Try turning the instrument OFF/ON. Ensure that the power supply to instrument and power source are good. Ensure that fuses are good. If turning the instrument OFF/ON does not work, call your Beckman Coulter Representative. Turn instrument OFF. If this occurs, reseat the software card and turn ON the power. If the problem still persists, obtain a new software card. If problem persists, call your Beckman Coulter Representative. The Probe has 4 horizontal and 3 vertical probe positions. When the probe is sent to, but does not reach, a position, an error is generated describing the position that was not reached. Turn the power OFF and move the probe vertically and horizontally. Make sure there is no binding and there is nothing in the mechanisms path as it moves. Leave the probe in a central position horizontally and vertically. Turn the power ON. If the problem returns, check any probe movement that occurred. No attempt at movement indicates a motor or motor connection problem. Erratic motion could indicate a motor problem or a mechanism problem. Normal motion that seems to go into and past the proper position indicates a sensor or sensor connection problem. If problem persists, call your Beckman Coulter Representative.
DVM Error
Unexpected Software Condition Probe Did Not Reach Up Position Probe Did Not Reach Down Position Probe Did Not Reach Thief Position Probe Did Not Reach Closed Vial Position Probe Did Not Reach WBC Position Probe Did Not Reach RBC Position Probe Did Not Reach Open Vial Position Diluent Pump Did Not Reach Home I2C (Internal Communication Failure)
6 7 8 9 10 11 19 12 16
An attempt was made to home the diluent FMI pump. The home sensor was not seen. Each motor in the instrument has its own microprocessor to control it. A problem has occurred with communication between the main and motor processors. When problems occur with this communication process, this error is generated. All the components in question are found on the Analyzer card. Turn instrument OFF then ON. If problem persists, call your Beckman Coulter Representative.
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SERVICE AND MAINTENANCE SYSTEM ERRORS
Table 6.6 System Errors (Continued)
Number
Description Insufficient vacuum at beginning of cycle.
Probable Cause/Suggested Action Leak or plug in vacuum system or problem with vacuum pump. Ensure that the vacuum pump is ON. Check the vacuum isolator system for leaks, plugs or fluid buildup. Ensure that there are no plugs near the vacuum source, such as a plug in the fluid barrier (green striped). Other problems may be with the pneumatic solenoids or vacuum sensor.Turn instrument OFF then ON. If problem persists, call your Beckman Coulter Representative.
20 21
Sample Pump Did Not Reach Home Lyse Pump Did Not Reach Home
An attempt was made to home the sample FMI pump. The home sensor was not seen. An attempt was made to home the lyse FMI pump. The home sensor was not seen.
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SERVICE AND MAINTENANCE TROUBLESHOOTING GUIDES
6.13 TROUBLESHOOTING GUIDES

Tables 6.7 through 6.10 are troubleshooting guides. Each table details problems/situations, states the probable causes, and suggests actions for solving the situations.
Table 6.7 Power Problems Situation Screen is dark Power LED is lit. Probable Cause Suggested Action Touch the screen to brighten it. If the continue icon appears in the status field, touch it to prime the system.
ACT diff 2 analyzer dims the screen if you do not use the instrument for 15 minutes and also requires a prime if you do not use it for 2 hours.
Power will not turn on.
Power cord loose or not securely Make sure power cord is securely connected to instrument connected to wall or instrument. and wall. Turn power OFF. No voltage or wrong voltage at laboratory power outlet. Defective power switch. Instrument malfunction. Turn power ON. Make sure voltage is on and outlet is 90-264 Vac. Fuse is blown. Replace according to the Replacing Fuses procedure. Call your Beckman Coulter Representative. Call your Beckman Coulter Representative.
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Table 6.8 Aspiration Problems Situation No aspiration takes place 1. Probable Cause Tubing Problem. Plug or leak in tubing from aspirate probe to aspirate pump. Problem with connection to sample pump. 1. Suggested Action Inspect tubing for leaks, kinks or plugs. Also inspect tubing to LV11 and LV12. .
2.
2.
Check to see that the connector to the 50 L sample pump is tight and there is no air in the tubing or syringe. Leave pump, and check for motor movement when aspiration should be occurring.
3. Incomplete aspiration
The sample pump is not working.
3.
It is very difficult to tell an incomplete aspiration when you are aspirating only 12 L. This conclusion can only be arrived at by analyzing the results. WBC, RBC, Hgb and Plt would have to be low, with MCV normal. 1. Fluid drips from inside the probe. Fluid drips outside the probe.
Check for the same problems as above. They will be partial leaks or plugs instead of pulled-off tubes or total plugs.
Sample drips from probe after aspiration.
1.
This is a leak in the aspiration pathway. Check the same tubing and components as above for leaks. The probe wipe is not working. Check for leaks in the tubing to the probe wipe, a plug in the lower waste port of the probe wipe, a plug in the tubing between the lower probe wipe port and the Vacuum Isolator Chamber, a vacuum leak at the Vacuum Isolator Chamber, or no vacuum. Check to ensure that the vacuum pump is turned on and is working. (Vacuum pump is in right side door.) If air is in these lines, check the components and tubing for partial or no aspiration. Check for leaks in pinch tubing at LV8. A leak from the reservoir to the sample pump assembly will cause air to be in the line to the aspirate probe. This would involve the tubing and the sample pump.
2.
2.
Bubbles in aspirator tubing between tip and aspirator pump.
1.
Leak from sample pump to aspirate tip. Leak between diluent reservoir and aspiration pump assembly.
1.
2.
2.
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Table 6.9 Background Problems Situation WBC, RBC and Plt exceed limits. Hgb may also be high in noted instances. 1. Probable Cause Contaminated diluent. 1. Suggested Action Replace diluent. Do a prime and startup. If you suspect biological contamination, perform Heading 6.7, PREPARING TO SHIP THE INSTRUMENT. This allows you to cycle bleach through all appropriate tubing and components. Run several startups to remove any contamination. Perform the Cleaning (Bleaching) the Baths procedure (under Heading 6.3).
2.
Contaminated baths. This can be caused by a cleaning solution left in the baths for an extended period of time. Many bubbles in both baths.
2.
3.
3.
Check the system for bubbles, starting with the fluid reservoir and moving on to the sample and diluent pumps. Remove the bath shield and run a cycle, observing the fluid in the baths if necessary. Repair any leaks that have caused the bubbles, whether tubing, fitting, or component. Do high/low carryover checks (see Heading 6.4). Backgrounds should pass or be very close on the first blank. If they are high and then fall on subsequent cycles, there could be blood left over from the previous cycle.
4.
Blood in the aspiration path 4. before the background aspiration. The instrument guards against this and any problem that circumvents the system would usually cause some other error on the previous cycle. Electrical interference. This will usually affect only the counts, not Hgb 5.
5.
Ensure that the bath shield is on the plate that the baths are mounted to, including the bath shield, is not connected to the main instrument. Ensure no electrical connection is made, including salt buildup that could connect the shield or plate to the main instrument chassis. Ensure there are no fluid spills in and around the bath area. Ensure that no electrical equipment, especially motorized equipment, is operating near the instrument. Check the power source. Check that no motorized piece of equipment is plugged into the same power circuit. Ensure that the ground connection at the outlet is good.
6.
7. 8.
9.
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Table 6.9 Background Problems (Continued) Situation Only WBC results exceed background specifications. 1. 2. Probable Cause Contamination to a smaller degree than above. 1. Suggested Action Redo startup. Proceed as above if problem persists. Check the bath during count for excessive mixing bubbles. Check the lytic reagent (yellow tubing) system for leaks, air bubbles.
Bubbles in bath. Since only 2. WBC is affected, the source is either incorrect mixing bubbles to the WBC bath or air in the lytic reagent system. Electrical interference. This 3. generally affects WBC and/or Plt first, since they normally produce smaller count pulses than the RBC. Excessive mixing bubbles. 1.
3.
See above. Problem could also be with WBC bath/aperture assembly, connection to the Analyzer card, or the Analyzer card itself.
Only RBC results exceed background specifications.
1.
Check green stripe tubing to bottom of RBC bath for partial obstructions and replace the tubing, if necessary. Perform a sweepflow prime. Watch the tubing in the sweepflow spool for air bubbles. If the line does not prime, look for air leaks in the tubing from the reservoir to the sweepflow tubing. See above.
2.
Air in sweepflow. This may also affect Plt backgrounds. Plts are the smallest pulses measured. Any problem that affects all the other count parameters will affect Plts first. Depending how bad the problem is, only Plts may be affected. This includes contamination, bubbles, sweepflow problems, and electrical interference.
2.
Only Plt results exceed background specifications
1.
1.
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Table 6.10 Irregular Sample Results Situation All counted parameters are consistently lower than normal. MCV is normal. 1. 2. Probable Cause Short sample. Poor bath drain. 1. 2. Suggested Action See aspiration problems in Table 6.8. Leaks or plugs are in drain path. LV12, LV15, or LV18 has a problem. Plugged filter to waste pump. Waste pump has a problem. Check that probe wipe is working and not dripping into sample. See aspiration problems in Table 6.8. Check for signs of blood left on probe at end of cycle. Check for blood left at lower probe wipe fitting when probe has just retracted. Check for air in diluent path from the sample or diluent pump, to probe and to side fitting at bottom of bath. Check for diluent leaks at bottom of WBC bath. See high backgrounds in Table 6.9. See high backgrounds in Table 6.9.
3. All counted parameters are consistently higher than normal. MCV is normal. 1.
Diluted sample. Incomplete probe wipe.
3. 1.
2.
Insufficient diluent for dilution.
2.
All counted parameters are consistently higher than normal. WBC and Plt are too high or low, Hgb and RBC are opposite, too low or high. Parameters generally erratic with no specific high/low trend. Samples run in Predilute mode have erratic parameters. WBC results are higher than normal.
1. 2.
Contamination Electrical interference
1. 2.
Sample was not mixed adequately before aspiration. Poor or no mix bubbles in bath.
Remix sample and cycle again.
Check green striped tubing at bottom of baths for leaks or plugs. Inspect or replace the check valves in these lines. LV3 and LV4 may have problems. They are at the other end of the green striped tubing. Verify predilution. Make a dilution using larger volumes or use the Verify Predilute icon in the Diagnostics Function screen. 1. 2. Air bubbles or leak in lytic reagent system. Check reagent lines as above. Check for mixing bubbles after lytic reagent has been added. These bubbles enter lower right side port of WBC bath. Check the green stripe tubing, the check valve in this tubing, and LV4. See electrical interference and backgrounds in Table 6.9. Do a background and see if it passes. Replace WBC aperture bath assembly.
Incorrect or contaminated predilute dilution. 1. 2. Insufficient lytic reagent. Insufficient mix bubbles to WBC dilution.
3. 4.
Electrical interference.
3.
4. Cracked aperture. This will generally cause WBC Aperture Alerts before the affect to results is noticeable.
WBC and Hgb results are higher than normal.
Check for insufficient lytic reagent as above. Insufficient lytic reagent in dilution. More severe case than above. Will get WBC voteouts or Aperture Alerts frequently.
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Table 6.10 Irregular Sample Results (Continued) Situation WBC results are lower than normal. 1. Probable Cause Protein buildup on aperture. 1. Suggested Action Perform several zap aperture functions from the Diluter Functions screen. If this is not sufficient, bleach the apertures and baths using the clean baths icon from the Diluter Functions screen (in the Diluter Functions section of this chapter). Check the red stripe tubing leaving the rear of the bath, going to LV17, and going from LV17 to the VIC. A plug in LV17 or in the fitting entering the VIC is also a possibility. Check for fluid and salt deposits on outside of bath and Hgb components. Remove, clean and dry, if necessary. If there is fluid, find the source and repair if necessary. The diluent rinse and dilution prefill come from the diluent FMI pump. Correct any leaks and air in this system.
2.
Problem with vacuum draw to aperture. This will cause an Aperture Alert before the results are noticeably low. Fluid in optical path outside of bath.
2.
Hgb results are erratic.
1.
1.
2.
Bubbles in blank rinses. 2. Blanks are taken on the rinse that is in the bath before aspiration takes place and the WBC prefill. The prefill will be more suspect. Abnormal sample interfering with Hgb. 3.
3. RBC, MCV and Plt are affected. 1.
Run several other samples to see if problem is unique to original sample. Check for mixing bubble problems or leaks in the diluent path from the pump to the bath and probe. See above. Perform the Sweepflow function from the Diluter Functions screen (see Table 6.2). Ensure that fluid moves in the sweepflow system and that all bubbles have been removed. Air in diluent, possible leak. See above. Air in aspiration path after sample delivered to WBC bath, causing aspiration problems for RBC aspiration. RBC dilution aspirates fluid from WBC bath after initial delivery and mix. If level in bath is too low, or probe barely reaches level, results are low. Partial plug or leak in aperture area, red tube from rear of bath to Vacuum Isolator Chamber (VIC), LV16, or tubing port on VIC. A severe blockage or leak could cause an Aperture Alert.
1. Inadequate mixing or bubbles remaining during count. Sweepflow problem. 2.
2.
RBC, Plt incorrect
1. 2.
Dilution problem. Aspiration problem.
1. 2.
3.
Aperture sampling problem.
3.
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Table 6.10 Irregular Sample Results (Continued) Situation MCV only incorrect. 1. Probable Cause Protein buildup on aperture, causing elevated MCV. If this problem gets worse, Plts and RBCs are affected. A high frequency of RBC Aperture Alerts occurs. Cracked aperture resulting in low MCV. If the crack is bad, RBC Aperture Alerts will occur. Also the RBC and Plt counts will increase. Electrical interference. Since Plts produce the smallest pulses analyzed by the system, low level electrical interference affects Plts only. Contamination by small particles could also affect Plts only. This is not common, since contamination usually involves a wide size range of particles. Fluid in sweepflow, but sweepflow is not moving. This could be a plug or an air lock that low vacuum cannot break. 1. Suggested Action Perform the Clean Baths function from the Diluter Functions screen (see Cleaning (Bleaching) the Baths under Heading 6.3).
2.
2.
If this is the problem, you must replace the RBC aperture bath. Call your Beckman Coulter Representative.
Plt only incorrect
1.
1.
See electrical interference under background problems, Table 6.9.
2.
2.
Change diluent. If the instrument is badly contaminated, especially with biological growth, run the Prepare to Ship procedure from the Diagnostic Functions screen.
3.
3.
Perform the Sweepflow prime from the Diluter Functions screen. This function primes the sweepflow with high vacuum. Make sure that fluid is moving. If not, a plug or a leak in the sweepflow check valve could be the problem.
Whole blood results similar Undiluted whole blood was to pattern below: analyzed in the Predilute WBC - - - - - x 103 cells/L mode. RBC +++++ x 106 cells/L Hgb +++++ g/dL Hct +++++ % MCV +++++ fL MCH 40 pg MCHC 15 g/dL Plt 0 x 103 cells/L
Select Whole Blood mode and rerun the patient sample. Clean aspirate system by doing primes and/or Startup.
PN 4237495BA
6-99
6-100
PN 4237495BA
AMANUAL CALIBRATION A
A.1 ANALYSIS PROCEDURE
Use a material with known reference values as your calibrator.
Be sure you have done Precalibration Checks, Reproducibility, and Carryover. See Chapter 5 for details.
Prepare your material as needed.
At the Main screen, select the Closed Vial

Whole Blood mode.
At the Main screen, touch the Sample Results icon.
PN 4237495BA
A-1
MANUAL CALIBRATION ANALYSIS PROCEDURE
Place the well-mixed material in the tube holder and close the door.
When the door opens, remove the tube from the tube holder.
A-2
PN 4237495BA
MANUAL CALIBRATION ANALYSIS PROCEDURE
Record the results on the calibration worksheet.
CALIBRATION WORKSHEET
Sample Number 1 2 3 4 5 6 7 8 9 10 11 TOTAL MEAN (A) ASSIGNED VALUE (B) ABSOLUTE DIFFERENCE (C) CALIBRATION REQUIRED CURRENT CALIBRATION FACTOR (D) NEW CALIBRATION FACTOR (E) WBC RBC Hgb MCV Plt
C=B-A E = (B / A) x D
Repeat steps 4 and 5 ten times, for a total of 11 runs.
Do the Heading A.2, CALCULATIONS PROCEDURE.
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A-3
MANUAL CALIBRATION CALCULATIONS PROCEDURE
A.2
1
CALCULATIONS PROCEDURE
Calculate the mean for each parameter using samples 2 through 11 on the worksheet. Write this number into row A on the worksheet.
Copy your calibrator materials assigned value to the worksheet. Write this number into row B on the worksheet.
Calculate the absolute difference between the assigned value and the mean value calculated in step 1. Write this number into row C of the worksheet.
Determine if calibration is necessary by comparing the absolute difference from row C to your materials calibration criteria table. r If the absolute difference is less than the value in your materials calibration criteria table, no calibration is required. If the absolute difference is between the values found in your materials calibration criteria table, do Calculating New Calibration Factors. If the absolute difference is greater than the value found in your materials calibration criteria table, eliminate possible instrument problems and possible calibrator deterioration. If you determine calibration may be needed, call your Coulter Representative before calibrating.
A-4
PN 4237495BA
MANUAL CALIBRATION CALCULATING NEW CALIBRATION FACTORS
A.3
1
CALCULATING NEW CALIBRATION FACTORS

At the Main screen, touch the Setup icon.
At the Setup screen, touch the Calibration

Factors icon.
Record these factors into row D on the worksheet.
Calculate the new calibration factor using this formula: assigned value (B) new calibration factor = ---------------------------------------------- current calibration factor mean value (A) a. Divide the assigned value (row B) by the mean value (row A). Multiply the derived number from step a by the current calibration factor (row D). Record the new calibration factor into row E of the worksheet.
b.
c.
PN 4237495BA
A-5
Enter the new values on the Calibration Factors screen. Save the new values by touching the Save icon.
Verify that calibration is acceptable: a. b. Analyze a material with known values, such as 4C PLUS cell control. Be sure that the results fall within the expected ranges. If they do not, run one more sample. If the results still do not fall within the expected ranges, call your Coulter Representative.
c.
A-6
PN 4237495BA
Calibration Worksheet
Sample Number 1 2 3 4 5 6 7 8 9 10 11 TOTAL MEAN (A) ASSIGNED VALUE (B) ABSOLUTE DIFFERENCE (C) CALIBRATION REQUIRED CURRENT CALIBRATION FACTOR (D) NEW CALIBRATION FACTOR (E) WBC RBC Hgb MCV Plt
A = samples 2 through 11 C=B-A E = (B / A) x D
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A-7
A-8
PN 4237495BA
BTUBES AND ADAPTERS B

B.1 TUBES
Table B.1 lists the tubes and tube adapters approved for use with the ACT diff 2 analyzer.
Table B.1 Closed Vial Sample Tubes Fill Volume (mL) 2.5 3.5 4.0 5.0 2.0 5.0 5.0 3.0 5.0 2.0 2.0 3.0 3.0 4.0 4.0 3.0 2.0 3.0 4.0 1.8 3.0 3.0 5.0 4.0 940712 940713 388873KE4/GL 388872KE2.5/GL 389082KE4/GL 389173KE4/GL 05.1167.100 5.0 5.0 4.0 2.5 4.0 4.0 2.7 12.2 x 84 x 7.6 12.2 x 84 x 7.6 11.5 x 81 x 5.0 Dimensions (mm) (O.D. x Length x Pierce Diameter) 12.2 x 80 x 6.0 15.2 x 80 x 6.0 15.2 x 80 x 6.0 12.2 x 80 x 6.0 12.2 x 80 x 6.0 12.2 x 80 x 6.0 12.2 x 80 x 6.0 12.2 x 80 x 6.0 12.2 x 80 x 6.0 12.2 x 80 x 6.0 12.2 x 80 x 6.0 12.2 x 80 x 6.0 12.2 x 80 x 6.0 12.2 x 80 x 6.0 12.2 x 80 x 6.0 12.7 x 66 x 5.0 12.2 x 80.6 x 4.5 12.2 x 80.6 x 4.5 12.2 x 80.6 x 4.5 11.5 x 60 x 3.2 11.5 x 80 x 3.2 12.2 x 82 x 7.0 12.2 x 82 x 7.0
Tube Manufacturer and Name Becton-Dickinson VACUTAINER Becton-Dickinson VACUTAINER Becton-Dickinson VACUTAINER Becton-Dickinson VACUTAINER Becton-Dickinson HEMOGARD Becton-Dickinson HEMOGARD Becton-Dickinson HEMOGARD Becton-Dickinson HEMOGARD Becton-Dickinson HEMOGARD Becton-Dickinson HEMOGARD Becton-Dickinson HEMOGARD Becton-Dickinson HEMOGARD Becton-Dickinson HEMOGARD Becton-Dickinson HEMOGARD Becton-Dickinson HEMOGARD Beckman Coulter 4C Greiner VACUETTE Greiner VACUETTE Greiner VACUETTE Kabe Kabe Labco Exetainer Labco Exetainer Labo Express Service LDM LDM LIP LIP LIP LIP Sarstedt Monovette w/Hollow Plastic Plunger
Product Number 6405 6458 6545 6452 367651 367653 367658 367661 367662 367841 367842 367856 367859 367861 367862 4C 454087 454086 454036 E201N E301N 35241S140 35271S159
PN 4237495BA
B-1
TUBES AND ADAPTERS TUBE LIMITATIONS
Table B.1 Closed Vial Sample Tubes (Continued) Fill Volume (mL) 3.0 5.0 Dimensions (mm) (O.D. x Length x Pierce Diameter) 12.2 x 80 x 6.5 12.2 x 80 x 6.5 12.5 x 80 x 5.0 15.5 x 80 x 5.0 0.25 to 0.50 2.0 10.2 x 46 x 5.0 11.5 x 81 x 6.0
Tube Manufacturer and Name Sherwood Medical Sherwood Medical Terumo VENOJECT Terumo VENOJECT Becton-Dickinson Microtainer w/Pierceable Cap* Becton-Dickinson MidRange w/False Bottom Becton-Dickinson MidRange w/False Bottom
Product Number 8881-314440 8881-311446 T-206QS T-202SQS 365991 368241 (Europe) 368247 (U.K./Asia) 368261 (USA) 368242 (Europe) 368248 (U.K./Asia) 368262 (USA)
3.0
11.5 x 81 x 6.0
Blank indicates Not Available. * indicates that Coulter Tube Adapter PN 1020854 is required.
B.2
TUBE LIMITATIONS
r Except for Becton-Dickinson Microtainer w/Pierceable Cap (365991), all tubes should contain a minimum of 1 mL sample when running in the Closed Vial Whole Blood mode. Beckman Coulter recommends that the tubes in Table B.1 be run no more than 11 times each in Closed Vial Whole Blood mode.
The following sample tube types and general sample tube attributes (Table B.2) cannot be used with the ACT diff 2 analyzer:
Table B.2 Types of Tubes Not For Use with ACT diff 2 Analyzer Tube Sarstedt Monovette with a solid rubber plunger r r r r r r Tube Types Tubes equivalent to the Sarstedt Monovette with a solid rubber plunger Tubes with an outside diameter of >16 mm or <11.5 mm. Tubes with length of >85 mm, including cap. Tubes with length of <55 mm when measured from the tube bottom to the base of the cap. Tubes with a pierce diameter of <3.2 mm. Tubes with cap configurations that trap fluid on underside when the tube is oriented with the cap up.
B-2
PN 4237495BA
TUBES AND ADAPTERS TUBE ADAPTER
B.3
TUBE ADAPTER
Certain tubes listed in Table B.1 require the use of the Tube Adapter. The tube will either fit inside the tube adapter or the tubes cap will rest on top of the tube adapter. See Table B.3. Note: Certain tubes will not fit into the adapter if more than two self-adhesive labels are applied in addition to the manufacturers label. Note: Beckman Coulter does not recommend the use of glass tubes with the Tube Adapter.
Table B.3 Tube Adapter Usage Description Tube adapter with tube that fits entirely inside. Illustration Removing Tubes from Tube Adapter
Tube adapter with tube that does not fit entirely inside; tube cap rests on top of adapter.
PN 4237495BA
B-3
TUBES AND ADAPTERS TUBE ADAPTER
B-4
PN 4237495BA
REFERENCES
1. 2. 3. 4. Coulter WH. High speed automatic blood cell counter and cell size analyzer. Paper presented at National Electronics Conference, Chicago, IL, 1956; October 3. Brecher GM, Schneiderman M and Williams GZ. Evaluation of electronic red blood cell counter. Am J Clin Path, 1956; 26:1439-1449. Brittin GM, Brecher G and Johnson CA. Evaluation of the COULTER COUNTER Model S. Am J Clin Path, 1969; 52:780-783 Gottmann NAW. Multiple hematologic analyses by means of a COULTER COUNTER Model S. Paper presented at International Symposium of Standardization of Hematological Methods, Fondazione, Carlo Erba, Milan, Italy, November 9 and 10, 1970. Symposium proceedings published in Haematologica Latina, 1969. Hamilton PJ and Davidson RL. The interrelationships and stability of Coulter S-determined blood indices. J Clin Path, 1973; 16:700-705. Bessman JD and Johnson RK. Erythrocyte volume distribution in normal and abnormal subjects. Blood, 1975; 46:369-379. Price-Jones. The diameter of red cells in pernicious anaemia and in anaemia following haemorrhage. J Path Bact, 1922; 25:487-504. England JM, Walford DM and Waters DAW. Reassessment of the reliability of the haematocrit. Brit J Haemat, 1972; 23:247-256. Bull BS, Schneiderman MA and Brecher G. Platelet counts with the COULTER COUNTER. Am J Clin Path, 1965; 44(6):678-688.
5. 6. 7. 8. 9.
10. Mundschenk DD, et al. An improved technique for the electronic measurement of platelet size and shape. J Clin Lab Med, 1976; 88(2):301-315. 11. Schulz J and Thom. Electrical sizing and counting of platelets in whole blood. Med Biol Engr, 1973; 73:447-454. 12. Von Behrens. Mediterranean macrothrombocytopenia. Blood, 1975; 46(2):199-207. 13. Paulus JM. Platelet size in man. Blood, 1975; 46(3):321-336. 14. International Committee for Standardization in Haematology. Recommendations for reference method for haemoglobinometry in human blood (ICSH Standard EP6/2:1977) and specifications for international haemiglobincyanide reference preparation (ICSH Standard EP6/3: 1977) J Clin Path, 1978; 31(2):139-143. 15. Gauthier et al. Human leukocytes: their size distribution and mean corpuscular volume. Can Med Assn J, 1967; 97:793-796. 16. Hughes-Jones NC et al. Differential leukocyte counts by volume distribution analysis. Brit J Hem, 1974; 28(1):148. 17. England JM et al. A semi-automatic instrument for estimating the differential leukocyte count. Biomed Engr, 1975; 10(8):303-304. 18. Wycherley PA and O'Shea MJ. Abridged differential leukocyte counts provided by a COULTER Channelyzer in a routine haematology laboratory. J Clin Path, 1978; 31(3):271-274.
PN 4237495BA
REFERENCES-1
REFERENCES
19. Oberjat TE, Zucker RM and Cassen B. Rapid and reliable differential counts on dilute leukocyte suspensions. J Lab Clin Med, 1978; 76(3):518-522. 20. Cox C et al. Evalution of COULTER, three part differential system. Am J Clin Path, 1984; 82(3):372-373. 21. Richardson, Jones A. Evaluation of the Coulter histogram differential: a review of the literature, 1986. Coulter Electronics, Inc., Hialeah, FL 22. Allen JK and Batjer JD. Evaluation of an automated method for leukocyte differential counts based on electronic volume anlaysis. Arch Pathol Lab Med, 1985; 109(6):534-539. 23. Cornbleet J and Kessinger S. Evaluation of Coulter S-Plus three-part differential in populations with a high prevalence of abnormalities. Am J Clin Path 1985; 84(5):620-626. 24. Cornbleet J, Kessinger S and Bollinger PB. New data from automated hematology instruments: technical and clinical applications. ASCP National Meeting, San Francisco, April, 1987. 25. Greendyke RM et al. A comparison of differential white blood cell counts using manual technic and the Coulter S-Plus IV. Am J Clin Path, 1985; 84(3):348-350. 26. Griswold D and Champagne VD. Evaluation of the Coulter S-Plus IV three-part differential in an acute care hospital. Am J Clin Path, 1985; 84(1):49-57. 27. Eckhoff RF An experimental indication of the volume proportional response of the . Coulter Counter for irregularly shaped particles. J Sci Inst, 1967; 44:648-649. 28. Grover NB, Naaman J, Ben-asson S and Dojanski F Electrical sizing of particles in . suspension III. Rigid spheroids and red blood cells. Biophys J, 1972; 12:1099-1116. 29. Waterman CS, Atkinson EE, Wilkins B, Fischer CL and Kimsey SL. Improved measurement of erythrocyte volume distribution by aperture-counter signal analysis. Clin Chem, 1975; 21:1201-1211. 30. Kachel V and Ruhenstroth-Bauer G. Methodik and Ergebissne Optiseher Formfatorunter-suchungen bei der Zellvolumenmessung nach Coulter. Micros Acta, 1976; 75:419-423. 31. Luke RG, Koepke JA and Siegel RR. The effect of immunosuppressive drugs and uremia on automated leukocyte counts. Am J Clin Path 11971; 56:503-507. 32. Koepke JA. Drug interference with leukocyte counting (spurious leukopenia). Drug Therapy, 1974; 79. 33. Dale NL and Schumacher HR. Platelet satellitism -- new spurious results with automated instruments. Lab Med, 1982; 13:300-304. 34. Kjeldsberg CR and Hershgold EJ. Spurious thrombocytopenia. JAMA, 1974; 227:628-630. 35. Brittin GM, Brecher G, Johnson CA and Stuart J: 1969. Spurious macrocytosis of antibody-coated red cells. Am J Clin Path 52:237-241.
REFERENCES-2
PN 4237495BA
REFERENCES
36. Hattersley PG, Gerard PW, Caggiano V and Hash DR. Erroneous values on the COULTER COUNTER Model S due to high titer cold autoagglutinins. Am J Clin Path, 1971; 55:442-446. 37. Nosanchuk JS, Roark MF and Wanser C. Anemia masked by triglyceridemia. Am J Clin Path, 1974; 62:838-839. 38. Fales W. Water distribution in blood during sickling of erythrocytes. Blood, 1978; 51:703-709. 39. Richardson-Jones A. Mean platelet volume: clinical utility and the variables of measurement. 1986; Coulter Electronics, Inc., Hialeah, Florida.
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REFERENCES-3
REFERENCES
REFERENCES-4
PN 4237495BA
GLOSSARY
Accuracy Ambient Assay Assay Values Assigned Values Aspirate-Verify Cycle Background Count Background Cycle Baud Blank Cycle Calibration Calibration Factors Calibrator Carryover Cell Control Clean Baths Cycle Cleanup Cycle Closed Vial Mode Codes Coefficient of Variation Coincidence Control Coulter Histogram Differential (CHD) Coulter Principle Conventions CV Data Bit Defaults Diluter Dispense Diluent Cycle Ability of the instrument to agree with a predetermined reference value at any point within the operating range; closeness of a result to the true (accepted) value. Surroundings or environment. Procedure of repeat testing to determine the assigned value for a given lot and level of control. Values of all parameters in a control established by extensive assay of that control. Values of all parameters in a calibrator established by extensive testing of that calibrator. Aspirates 20 L of whole blood. Measure of the amount of electrical or particle interference. Ensures that instrument is ready to run. A rate defining how many data bits per second are transferred during communications between two pieces of equipment. Runs diluent through the system to clean it out. A procedure to standardize the instrument by determining its deviation from calibration references and applying any necessary correction factors. These are correction factors that the system uses to fine-tune instrument accuracy. A substance traceable to a reference method for preparation or material used to calibrate, graduate, or adjust a measurement. The amount, in percent, of blood cells or Hgb remaining in diluent following the cycling of a blood sample. A preparation made of human blood with stabilized cells and surrogate material. It is used for daily instrument quality control. You present bleach at the sample probe for aspiration into the baths; alternative to Shutdown. Cleans up the system during powerup. Primary sample analysis mode for processing samples that can be cap pierced. On printouts, symbols such as +++++, -----, ....., +, * that appear in place of sample results. See Heading 9.18, WHAT FLAGS AND CODES MEAN for additional information. An expression, in percent, of data (SD) spread as related to the mean. %CV = (SD / mean) 100 More than one cell within aperture sensing boundaries at the same time. The system senses these as one large cell rather than as two distinct cells, so it generates one large pulse. A substance used for monitoring the performance of an analytical process or instrument. How the computer computes absolute numbers for each population of LY, MO, and GR. W.H. Coulters method for counting and sizing cells and particles. Standard style or format used in a particular manual. (see Coefficient of Variation) Computer code used to transfer each character of information. Original settings in the instrument. You can change these to tailor operation to your situation. Prepares the proper dilutions for sample analysis. Provides the proper amount of diluent for preparation of a prediluted sample.
PN 4237495BA
GLOSSARY-1
GLOSSARY
Dispense Lyse Cycle Dispense-Verify Cycle Drain Cycle Dry Prime Diluent Cycle
Dispenses lyse into the WBC bath. Dispenses proper volume of diluent for preparation of a prediluted sample with 20 L of whole blood aspirated by the aspirate-verify cycle. Drains the RBC bath, WBC bath, and the vacuum isolator chamber. Primes the pickup tube and diluent reservoir. Fills the diluent path between the diluent container and the diluent reservoir, even if empty; it does not fill the diluent path between the diluent reservoir and the baths. Primes the lyse path of the fluidics system; fills the lyse path completely, even if empty. The last day when you can use that lot number of reagent, control or calibrator. Abbreviation for femtoliters. One quadrillionth (10-15) of a liter. Area on a screen for entering data. On printouts, letters (H, L, *, +) that appear next to parameter results to indicate specific conditions. See Heading 9.18, WHAT FLAGS AND CODES MEAN for additional information. Measurement of hemoglobin in the blood. In COULTER instruments, this is done by comparing the amount of light that passes through a diluted lysed sample in which the released Hgb has been chemically converted, with the amount of light that passes through a blank. Pictorial representation for commands or options on an instrument. Beckman Coulter provides this program which statistically compares your 4C PLUS cell control data to a group of other laboratories' control recovery data. The ability of an instrument to recover expected results (reference values or calculated values) for such parameters as WBC, RBC, Hgb and Plt at varying levels of concentration of these parameters within specified limits. A manufacturer's code that identifies when the reagent was manufactured. Arithmetic average of a group of data. Secondary sample analysis mode for processing samples that required the cap to be removed. Range of results over which the instrument displays, prints, and transmits data. Control result that falls outside the expected range. Components of blood that the instrument measures and reports. Method of detecting errors in data handling. The computer generates a parity bit such that the sum of the data bits and the parity bit are odd or even for each data word. Actual performance of the instrument. Targeted performance of the instrument based on established ranges and parameters. Performs appropriate checks to ensure system is functioning correctly and prepares the instrument for running. This cycle is part of the entire powerup procedure and cannot be directly selected.
Dry Prime Lyse Cycle Expiration Date fL femtoliters Field Flags Hemoglobinometry
Icon IQAP (Interlaboratory Quality Assurance Program) Linearity
Lot Number Mean Open Vial Mode Operating range Outlier Parameters Parity Performance characteristics Performance specifications Powerup Cycle
GLOSSARY-2
PN 4237495BA
GLOSSARY
Precision
Ability of the instrument to reproduce similar results when a sample is run repeatedly. Precision of the instrument is a %CV, or an SD for diff parameters, based on at least 31 replicate determinations of the same sample. Precision shows the closeness of test results when repeated analyses of the same material are performed. A measure of reproducibility. The process of preparing a minimal amount of blood specimen for analysis by dispensing diluent to an empty tube then adding the blood specimen.A prediluted sample is different than a whole-blood sample. See whole blood. Executes request sample analysis using the prediluted specimen. Closed Vial mode. Primes the fluidics path from the diluent reservoir through the sweepflow coil and the path between the RBC aperture and the vacuum isolator chamber. Prepares the Diluter to run samples if Diluter has been idle for 2 hours or more. Executes Request Sample Analysis using non-labile control as the specimen. A comprehensive set of procedures your laboratory sets up to ensure that the instrument is working accurately and precisely. A program card that manages your reagent usage. This procedure checks that the system gives similar results (within established limits) every time it measures the same sample. Also called precision. Drains the baths, supplies the rinse, and provides the air for mixing. Open Vial mode. A measure of variation within a group of samples or a population. Consecutive values that abruptly move from one side of the mean to the other then maintain a constant level. Cleans the fluidic lines and apertures to help prevent residue buildup, and turns off Hgb lamp. A program card that contains instructions to run the instrument. A measure of variation within a group of samples or a population. Ensures that the instrument is ready to run; includes turning on Hgb lamp and performing background test. A computer code that indicates the end of a character. A steady stream of diluent that flows behind the RBC aperture during sensing periods to keep RBCs from swirling back into the sensing zone. Assigned values for a control material used for quality control parameters. Usually reported on a package insert shipped with the control material; can be a separate assay sheet. Values that continue to increase or decrease gradually over a period of time. Procedure to analyze cell controls or whole blood with known values to determine if your control results are within expected range. Procedure that performs the aspirate-verify cycle followed by the dispense-verify cycle. In COULTER hematology instruments, the system compares the three counts for RBC, WBC, Plt. Unless at least two counts agree, the system does not accept the count. It displays a code (-----) to indicate a voteout. Primes the fluidics path of the Diluter and baths with diluent and removes small amounts of air that may have leaked into the diluent lines.
Predilute
Predilute Cycle Primary Mode Prime Sweepflow Cycle Prime Timeout Cycle Quality Check Cycle QC (Quality Control) Reagent Management Card Reproducibility Rinse and Mix Cycle Secondary Mode SD (Standard Deviation) Shift Shutdown Cycle Software Card Standard Deviation (SD) Startup Cycle Stop Bit Sweep Flow TABLE OF EXPECTED RESULTS Trend Verification Verify Predilute Voting
Wet Prime Cycle
PN 4237495BA
GLOSSARY-3
GLOSSARY
Whole Blood Whole Blood Cycle Zap Aperture Cycle
Non-diluted blood; blood and anticoagulant only. Executes Request Sample Analysis using whole blood as a specimen. Clears the aperture using the zap current circuit.
GLOSSARY-4
PN 4237495BA
ABBREVIATIONS
Abbreviation L m A AIM ANSI ASCII ASTM AWG bps CBC CDC CEE CHD cm CSA CV diff dL EDTA FDA fL ft g gal GR Hct Hgb Hz IEC IQAP L LY m MCH MCHC MCV microliter micrometer ampere aperture integrity monitor
Explanation
American National Standards Institute American Standard Code for Information Interchange American Society for Testing and Materials American Wire Gauge bits per second complete blood count Centers for Disease Control and Prevention Commission for Electrical Equipment Coulter Histogram Differential centimeter Canadian Standards Association coefficient of variation differential deciliter ethylenediaminetetraacetic acid Food and Drug Administration femtoliter foot or feet gram gallon granulocyte hematocrit hemoglobin hertz International Electrical Commission Interlaboratory Quality Assurance Program liter lymphocyte meter mean corpuscular hemoglobin mean corpuscular hemoglobin concentration mean corpuscular volume
PN 4237495BA
ABBREVIATIONS-1
ABBREVIATIONS
Abbreviation mL mm MO MPV MSDS mW n NCCLS NEMA nm pg Plt psi QA RBC RDW SD UL Vac Vdc VIC VRM WBC milliliter millimeter monocyte mean platelet volume material safety data sheets milliwatt number
Explanation
National Committee for Clinical Laboratory Standards National Electrical Manufacturers Association nanometer picogram platelet pounds per square inch quality assurance red blood cell red cell distribution width standard deviation Underwriters Laboratory volts of alternating current volts of direct current vacuum isolator chamber Volts Root Mean Square white blood cell
ABBREVIATIONS-2
PN 4237495BA
INDEX
Symbols
* WBC action recommended, 6-88 meaning of, 6-88 *Hct action recommended, 6-88 meaning of, 6-88 *Hgb action recommended, 6-88 meaning of, 6-88 *MCH action recommended, 6-88 meaning of, 6-88 *MCHC action recommended, 6-88 meaning of, 6-88 *MCV action recommended, 6-88 meaning of, 6-88 *MPV action recommended, 6-88 meaning of, 6-88 *Pct action recommended, 6-88 meaning of, 6-88 *PDW action recommended, 6-88 meaning of, 6-88 *Plt action recommended, 6-88 meaning of, 6-88 *RBC action recommended, 6-88 meaning of, 6-88 + action recommended, 6-87 meaning of, 6-87 ..... action recommended, 6-86 meaning of, 6-86, 6-87 when to run, 2-8
A
abbreviations list of, ABBREVIATIONS-1 CT Rinse shutdown diluent A replacement of, 6-31 accuracy definition of, GLOSSARY-1 ambient definition of, GLOSSARY-1 Analyzing Mode icon, 1-xviii aperture, 6-98 aperture alert, function of, 6-83 cracked, what happens if, 6-97, 6-99 zap, when to, 6-3 zapping, purpose of, 6-78 aspirate-verify cycle definition of, GLOSSARY-1 aspiration problems actions recommended, 6-94 air in aspiration path, 6-94, 6-98 bubbles in aspirator tubing, 6-94 causes of, 6-94 effect on sample results, 6-97 incomplete aspiration, 6-94 sample drips from probe after aspiration, 6-94 table of, 6-94 tubing, 6-94 assay values definition of, GLOSSARY-1 assigned values definition of, GLOSSARY-1 Auto ID icon, 1-xxi auto-calibration precalibration requirements, 5-2 procedure, 5-10
B
background counts, definition, GLOSSARY-1 cycle, definition, GLOSSARY-1 See also background problems background problems, 6-95 bubbles, 6-95, 6-96 contamination, 6-95, 6-96 diluent, 6-95 electrical interference, 6-95 INDEX-1
Numerics
2.5 A 250 V Slo Blo fuse location of, 6-48 4C PLUS cell control deleting files, 2-21 printing stored results, 2-12 procedure, 2-8
PN 4237495BA
INDEX
only Plt results exceed background specifications, 6-96 only RBC results exceed background specifications, 6-96 only WBC results exceed background specifications, 6-96 sweepflow, 6-96 troubleshooting, 6-95 WBC, RBC, and Plt exceed limits, 6-95 barrier, vacuum fluid replacement of, 6-34 baths, 6-99 cleaning the, 6-4 diluter screen, cleaning functions, 6-77 RBC, location, 6-18 sample results problems, 6-98 WBC, location, 6-18 baud definition of, GLOSSARY-1 blank cycle definition of, GLOSSARY-1
C
calibration automatic, 5-10
Calibration Factors, icon, 1-xix
definition of, GLOSSARY-1 description of, 5-1 factors, definition of, GLOSSARY-1 FAILED, what to do if, 5-17 frequency, 5-1 NEEDED, what to do if, 5-17 PASSED, what to do if, 5-17 preliminary procedure, 5-2 reproducibility procedure, 5-3 reproducibility, definition of, 5-3 S-CAL Calibrator kit, 5-10 when to do, 5-1 See also auto-calibration cards Analyzer, 6-91, 6-96 reagent management, 6-89 reagent management, used, 2-19 software, 6-91 carryover definition of, GLOSSARY-1 icon, 1-xix procedure, 5-7 cell controls INDEX-2
4C PLUS cell control, 2-8 definition of, GLOSSARY-1 deleting files, 4C PLUS, 2-21 downloading results for IQAP 2-19 , printing stored 4C PLUS cell control results, 2-12 CHD. See Coulter Histogram Differential check valves replacement of, 6-38 when to replace, 6-38 clean baths cycle definition of, GLOSSARY-1 Clean Baths icon, 1-xx cleaner. See ACT rinse shutdown diluent cleaning procedures cleaning (bleaching) the baths, 6-4 cleaning the closed vial door, 6-14 cleaning the closed vial station, 6-7 cleaning the fans dust filter, 6-16 cleaning the inside of the instrument, 6-7 cleaning the outside of the instrument, 6-7 when to perform, 6-3 zapping the apertures, 6-3 cleanup cycle definition of, GLOSSARY-1 closed vial mode, definition of, GLOSSARY-1 station, location of, 6-18 Closed Vial Whole Blood mode icon, 1-xviii codes definition of, GLOSSARY-1 replacement flags, same as, 6-80 coincidence correction coincidence, definition of, GLOSSARY-1 Continue icon, 6-93 control database not empty, changes made when, 2-1 conventions definition of, GLOSSARY-1 corrosive deposits, preventing, 6-7 Coulter histogram differential definition of, GLOSSARY-1 Coulter Principle definition of, GLOSSARY-1 count periods disagreement between, 6-81 counts high, consistently, 6-97 low, consistently, 6-97
PN 4237495BA
INDEX
CV definition of, GLOSSARY-1 cycle counter location of, 6-1 printing cycle count, 6-1 Cycle Counter icon, 1-xx cycles. See specific cycle name
D
Darken Screen icon, 1-xviii
data bit definition of, GLOSSARY-1 Date/Time icon, 1-xix default definition of, GLOSSARY-1 definitions of terms. See glossary Delete icon, 1-xxi diagnostic functions, 6-78 troubleshooting, 6-78 Diagnostic Functions icons, 6-79 Diagnostics icon, 1-xviii diff ACT PAK reagent management card, location of, 6-22 replacing the, 6-20 diff ACT Tainer reagent management card, location of, 6-27 replacing the, 6-25 diluent amount dispensed by instrument for prediluted samples, 6-79 contaminated, result if, 6-95 empty, result if, 6-90 leak, indications of, 6-89 wet prime, function of, 6-77 diluent pump error message, 6-91 location, 6-19 diluent reservoir location, 6-19 pump location, 6-19 Diluter, 1-xx definition of, GLOSSARY-1 functions, 6-98 troubleshooting, 6-77 Diluter Functions icons, 1-xviii, 6-77 dilution, creating a, 6-83, 6-97 dispense diluent cycle definition of, GLOSSARY-1 Dispense Diluent icon, 1-xxi
PN 4237495BA
dispense lyse cycle definition of, GLOSSARY-2 Dispense Lytic Reagent icon, 1-xx dispense-verify cycle definition of, GLOSSARY-2 drain baths, 6-77 cycle, definition of, GLOSSARY-2 path, 6-97 VIC, 6-77 Drain Baths icon, 1-xx dry prime diluent cycle definition of, GLOSSARY-2 Dry Prime Diluent icon, 1-xx dry prime lyse cycle definition of, GLOSSARY-2 Dry Prime Lytic Reagent icon, 1-xx DVM Error, 6-91
E
electrical interference, 6-95, 6-97 electronics failure, 6-89 pulse test, 6-79 Enter Patient ID icon, 1-xxi error messages flags, 6-81 system, table of, 6-91 error messages, warning, 6-89 errors, system See system errors Exit icon, 1-xix, 1-xx, 1-xxi
F
FAILED calibration parameters, 5-17 femtoliter. See fL fibrin strands what to do if found, 6-83 field definition of, GLOSSARY-2 filters replacement of, 6-36 fL definition of, GLOSSARY-2 flags actions required, 6-81 definition of, GLOSSARY-2 description of, 6-81
INDEX-3
INDEX
meaning of, 6-81 fluid drips, 6-94 FS3. See sensors fuses 2.5 A 250 V Slo Blo, location of, 6-48 replacement procedure, 6-45
Exit, 1-xix, 1-xx, 1-xxi Go to Main Menu, 1-xxi IN PROGRESS, 1-xxi Laboratory ID, 1-xix
G
glossary, GLOSSARY-1 Go to Main Menu icon, 1-xxi
H
H flag action recommended, 6-87 definition of, 6-87 hemoglobinometry definition of, GLOSSARY-2 Hgb . . . . ., description of, 6-86, 6-87 Hgb lamp location, 6-18 high counts, 6-97 horizontal traverse assembly location, 6-18
I
icons
4C PLUS, 1-xix Analyzing Mode, 1-xviii Auto ID, 1-xxi Calibration, 1-xix Calibration Factors, 1-xix Carryover, 1-xix Clean Baths, 1-xx Cycle Counter, 1-xx Date/Time, 1-xix
definition of, GLOSSARY-2

Delete icon, 1-xxi Diagnostic Functions Screen, 1-xx, 6-79 Diluter Functions, 6-77 Diluter Functions screen, 1-xix Dispense Diluent, 1-xxi Dispense Lytic Reagent, 1-xx Drain Baths, 1-xx Dry Prime Diluent, 1-xx Dry Prime Lytic Reagent, 1-xx Enter Patient ID, 1-xxi
main screen, list of, 1-xviii Motors, 1-xx Patient Limits, 1-xix, 1-xxi Patient Results, 1-xxi Prepare to Ship, 1-xx Prime Sweepflow, 1-xx Print Sample Results, 1-xxi Print Setup Report, 1-xix Printers/Profiles, 1-xix Pulse Test, 1-xx QA screen, 1-xix Reproducibility, 1-xix Resend to Host, 1-xxi Rinse + Mix, 1-xx Sample Details, 1-xx Sample ID Screen, 1-xxi Sample Results Screen, 1-xxi Save and Exit, 1-xxi setup screen, list of, 1-xix Solenoids, 1-xx Transmission, 1-xix Units, 1-xix Verify Predilute, 1-xx Voltages/Sensors, 1-xx warning messages, 6-89 Wet Prime, 1-xx Zap Apertures, 1-xx icons, main screen Analyzing Mode, 1-xviii Darken Screen, 1-xviii Diagnostics, 1-xviii Diluter Functions, 1-xviii Lighten Screen, 1-xviii Predilute Mode, 1-xviii Sample Results Screen, 1-xviii Setup, 1-xviii Shutdown, 1-xviii Startup, 1-xviii Whole Blood Mode, 1-xviii icons, setup screen Calibration Factors, 1-xix Date/Time, 1-xix Exit, 1-xix Patient Limits, 1-xix Print Setup Report, 1-xix
INDEX-4
PN 4237495BA
INDEX
Transmission, 1-xix Units, 1-xix
instrument components, location of, 6-18 shipping, preparing for, 6-71 Interlaboratory Quality Assurance Program. See IQAP IQAP definition of, GLOSSARY-2 downloading 4C PLUS cell control results, 2-19 laboratory quality control program, 5-1 irregular sample results all parameters, 6-97 aspiration problems, 6-97 contamination, 6-97, 6-99 diagnostic functions, 6-99 diluter functions, 6-98, 6-99 dilution problems, 6-98 electrical interference, 6-97, 6-99 Hgb, 6-98 insufficient lytic reagent, 6-97 insufficient mix bubbles, 6-97 MCV, 6-98, 6-99 Plt, 6-98, 6-99 predilute, 6-97 RBC, 6-98 sweepflow, 6-99 vacuum draw, 6-98
location, 6-19 LV10 location, 6-19 LV11 location, 6-19 LV12 location, 6-19 LV13 location, 6-19 LV15 location, 6-19 LV16 location, 6-18 LV17 location, 6-18 sample results problem, 6-98 LV18 location, 6-19 lyse pump location, 6-19 lytic reagent, 6-97 empty, what to do when, 6-90
M
maintenance general information, 6-1 procedures, 6-1 schedule of, 6-1 why is it important?, 6-1 manuals for your instrument icons, list of, 1-xvii using the manuals, 1-xv mean definition of, GLOSSARY-2 messages, system. See system errors messages, warning. See warning messages motors closed vial sample handler, location, 6-18 horitzontal traverse, location, 6-18 Motors icon, 1-xx
L
L flag action recommended, 6-88 definition of, 6-88 Laboratory ID icon, 1-xix lamps Hgb, location, 6-18 Hgb, turning ON, 6-89 Lighten Screen icon, 1-xviii linearity definition of, GLOSSARY-2 lot number definition of, GLOSSARY-2 low counts problem and corrective action, 6-97 LV4 sample results problem, 6-97 LV7 location, 6-19 LV8
PN 4237495BA
N
NEEDED calibration parameters, 5-17
O
Open Vial Mode
INDEX-5
INDEX
definition of, GLOSSARY-2

Open Vial Whole Blood mode icon, 1-xviii
Predilute Mode icon, 1-xviii Prepare to Ship icon, 1-xx
operating range definition of, GLOSSARY-2 outlier definition of, GLOSSARY-2
P
parameters definition of, GLOSSARY-2 parity definition of, GLOSSARY-2 PASSED calibration parameters, 5-17 Patient Limits icon, 1-xix, 1-xxi patient results Storage icon, 1-xxi PCMCIA Error, 6-91 performance characteristics, definition of, GLOSSARY-2 specifications, definition of, GLOSSARY-2 peristaltic pump description of, 6-90 pickup tubes cleaner, 6-31 Plt only incorrect parameter, 6-99 Plt+ action recommended, 6-87 meaning of, 6-87 PM1 peristaltic pump, 6-90 power problems, 6-93 cord, 6-93 defective power switch, 6-93 instrument malfunctions, 6-93 troubleshooting, 6-93 voltage, 6-93 powerup cycle definition of, GLOSSARY-2 precision definition of, GLOSSARY-3 predilute cycle definition of, GLOSSARY-3 predilute mode procedures for running sample, 3-15 running samples in, 3-14 verifying predilute, 6-79
preventive maintenance procedures, 6-1 Primary Mode definition of, GLOSSARY-3 prime, 6-20, 6-25, 6-99 diluent, 6-77, 6-90 lyse, 6-77 sweepflow, 6-77 wet, 6-77 prime sweepflow cycle definition of, GLOSSARY-3 Prime Sweepflow icon, 1-xx prime timeout cycle definition of, GLOSSARY-3 Print Sample Results icon, 1-xxi Print Setup Report icon, 1-xix printer warning, 6-89 Printers/Profiles icon, 1-xix probe location, 6-18 position of, 6-91 probe wipe block replacement, 6-2 block, location of, 6-18 problems, troubleshooting, 6-94 replacement of, 6-57 Pulse Test icon, 1-xx pumps diluent pump (100 L), location, 6-19 diluent reservoir, location, 6-19 diluent, error messages, 6-91 lyse pump (100 L), location, 6-19 PM1, peristaltic, 6-90 rinse pump, location, 6-19 sample pump (50 L), location, 6-19 waste/rinse, location, 6-19
Q
QA icons, 1-xix QC definition of, GLOSSARY-3 quality assurance. See QA quality check cycle definition of, GLOSSARY-3 quality control. See QC
INDEX-6
PN 4237495BA
INDEX
R
R flag definition of, 6-81 RBC bath location, 6-18 RBC+ action recommended, 6-87 definition of, 6-87 reagent management card definition of, GLOSSARY-3 reagents, 6-2, 6-90 ACT Rinse shutdown diluent, replacement of, 6-31 diff ACT PAK, replacement, 6-20 diff ACT Tainer replacement, 6-25 lytic, 6-97 references in manual list of, REFERENCES-1 replacement procedures check valve, when to replace, 6-2 fuse replacement, 6-45 fuse, when to replace, 6-2 probe wipe block replacement, 6-57 probe wipe block, when to replace, 6-2 reagents replacement, 6-20 reagents, when to replace, 6-2 tubing replacement, 6-43 tubing, when to replace, 6-2 vacuum fluid barrier replacement, 6-34 vacuum isolator chamber replacement, 6-48 vacuum isolator chamber, when to replace, 6-2 waste container replacement, 6-33 waste container, when to replace, 6-33 waste filter, when to replace, 6-2 reports calibration summary, example, 5-16 reproducibility definition of, 5-3, GLOSSARY-3 icon, 1-xix procedure, 5-3 sample criteria, 5-4 See also calibration Resend to Host icon, 1-xxi reservoirs leaks, causes of, 6-94 results sample results, irregular, 6-97 Rinse + Mix icon, 1-xx rinse and mix cycle
definition of, GLOSSARY-3 rinse pump location, 6-19
S
Sample Details icon, 1-xx
sample ID icons for screen, 1-xxi verifying, 3-3, 3-8, 3-11, 3-17 sample pump location, 6-19 sample results, 6-97 icons, screen, 1-xxi irregular. See irregular sample results Sample Results Screen icon, 1-xviii samples analyzing procedures, 3-2 how to run, 3-1 parameter criteria, reproducibility, 5-4 running in predilute mode, 3-14 running in whole-blood mode, 3-1 Save and Exit icon, 1-xxi S-CAL calibration kit, function of, 5-10 screen diagnostic functions, 6-78 diagnostics, 6-97 diluter functions, 6-77, 6-98 SD (Standard Deviation) definition of, GLOSSARY-3 Secondary Mode definition of, GLOSSARY-3 See also VIC sensors connection problem, result of, 6-91 waste, 6-33 Setup icon, 1-xviii shift definition of, GLOSSARY-3 shipping preparing instrument for, 6-71 shutdown cycle, definition, GLOSSARY-3 how to do, 6-1 icon, 1-xviii software card slot, location, 6-18 card, definition, GLOSSARY-3 solenoids INDEX-7
PN 4237495BA
INDEX
description of, 6-79 table of, 6-79 Solenoids icon, 1-xx standard deviation. See SD startup cycle, definition, GLOSSARY-3 when to perform, 6-1 Startup icon, 1-xviii stop bit definition of, GLOSSARY-3 sweep flow air in, result of, 6-96 definition of, GLOSSARY-3 icon, 6-77 prime procedure, 6-96 spool, location of, 6-18 switches aspirate, location, 6-18 system errors number 1, 6-91 number 3, 6-91 number 4, 6-91 number 6, 6-91 number 7, 6-91 number 8, 6-91 number 9, 6-91 number 10, 6-91 number 11, 6-91 number 12, 6-91 number 16, 6-91 number 19, 6-91 number 20, 6-92 number 21, 6-92 table of, 6-91
trend definition of, GLOSSARY-3 troubleshooting background problems, 6-95 Diagnostic functions, 6-78 Diluter functions, 6-77 power problems, 6-93 sample results, irregular, 6-97 tips for, 6-93 tools, 6-77 See also what to do if tube adapter how to remove tubes, B-3 illustration of, B-3 tubes for closed vial sampling, B-1 limitations for use, B-2 tubing, 6-94 replacement of, 6-43 vacuum isolator chamber, replacing in, 6-50 when to replace, 6-2
U
unexpected software condition description, 6-91 Units icon, 1-xix
V
vacuum adjust knob, location, 6-19 adjustment procedure, 6-55 problems, troubleshooting, 6-98 vacuum isolator chamber leak with tubing, 6-89 location, 6-18 replacement of, 6-48 sample results problem, 6-98 tubing replacement, 6-50 tubing, damaged, 6-50 when to replace, 6-2, 6-48 valves check valves. See check valves LV7, location, 6-19 LV8, location, 6-19 LV10, location, 6-19 LV11, location, 6-19 LV12, location, 6-19 LV13, location, 6-19
T
TABLE OF EXPECTED RESULTS definition of, GLOSSARY-3 where to find, GLOSSARY-3 test electronic pulse, 6-79 motors, 6-79 Time Keeper Failure, 6-89 transmission icon, 1-xix transmission incomplete problem and corrective action, 6-89 transmission to host failed problem and corrective action, 6-89 INDEX-8
PN 4237495BA
INDEX
LV15, location, 6-19 LV16, location, 6-18 LV17, location, 6-18 LV18, location, 6-19 verification definition of, GLOSSARY-3 VIC. See vacuum isolator chamber Voltage Failure, 6-89 Voltages/Sensors icon, 1-xx voteout, 6-81, 6-82 - - - - - flag, 6-81 definition of, GLOSSARY-3 voting definition of, GLOSSARY-3
W
warning messages, 6-89 actions recommended, 6-89 description of, 6-89 icons for, 6-89 waste full, 6-90 sensor, 6-33 waste container replacement of, 6-33 waste/rinse pump location, 6-19 WBC, 6-97 WBC bath, 6-89 location, 6-18 WBC XXXXX action recommended, 6-83 description of, 6-83 WBC+ action recommended, 6-87 meaning of, 6-87 wet prime cycle definition of, GLOSSARY-3 function, 6-77 Wet Prime icon, 1-xx what to do if bubbles appear in aspirator tubing between tip and pump, 6-94 Hgb is high, 6-95
Hgb results are erratic, 6-98 only MCV is incorrect, 6-99 only Plt is incorrect, 6-99 only Plt results exceed background specifications, 6-96 only RBC results exceed background specifications, 6-96 only WBC results exceed background specifications, 6-96 parameters are erratic for samples run in Predilute mode, 6-97 parameters are erratic without specific trend, 6-97 parameters are higher than normal, 6-97 parameters are lower than normal, 6-97 power LED is lit, 6-93 power will not turn on, 6-93 sample drips from probe after aspiration, 6-94 screen is dark, 6-93 undiluted whole blood was analyzed in Predilute mode, 6-99 WBC and Hgb results higher than normal, 6-97 WBC results are higher than normal, 6-97 WBC results lower than normal, 6-98 whole blood results are Hct +++++ %, 6-99 whole blood results are Hgb +++++ g/dL, 6-99 whole blood results are MCH 40 pg, 6-99 whole blood results are MCHC 15 g/dL, 6-99 whole blood results are MCV +++++ fL, 6-99 whole blood results are Plt 0 x 103 cells/L, 6-99 whole blood results are RBC +++++ x 106 cells/L, 6-99 whole blood results are WBC - - - - - x 103 cells/L, 6-99 whole blood mode, icon for, 1-xviii whole blood cycle definition of, GLOSSARY-4 Whole Blood Mode icon, 1-xviii
Z
zap apertures cycle, definition of, GLOSSARY-4 Zap Apertures icon, 1-xx
PN 4237495BA
INDEX-9
INDEX
INDEX-10
PN 4237495BA
TRADEMARKS
ACT diff 2, ACT Rinse, the Beckman Coulter logo, COULTER, , diff ACT Pak, diff ACT
Tainer, 4C, COULTER CLENZ, LIN-C, and S-CAL are trademarks of Beckman Coulter, Inc.
All other trademarks, service marks, products, or services are trademarks or registered trademarks of their respective holders.
PN 4237495BA
COULTER ACT diff 2 Analyzer Documentation
Reference PN 4237515 (*Black binding) Operators Guide PN 4237495 (*Red binding) Operating Summary PN 4237516 Installation and Training Guide diff ACT Tainer Reagent diff ACT Pak Reagent PN 4237517
Use and Function Installation Operation Principles Specifications/Characteristics Precautions/Hazards Host Transmission Specifications Log Sheets References Glossary Abbreviations Index Routine Procedures Cell Controls Running Samples Reviewing Results Calibration Service and Maintenance References Glossary Abbreviations Index Overview of daily procedures and screen icons. Installing the ACT diff 2 Analyzer Learning About the ACT diff 2 Analyzer Questions and Answers Component Locations Installation and Training Checklists
S S
* Binding colors apply to USA editions
Come visit us at www.beckmancoulter.com
Beckman Coulter Ireland, Inc. Mervue Business Park, Mervue Galway, Ireland 353 91 774068
Printed on Recycled Paper Copyright Beckman Coulter, Inc. 1999, 2003, 2010 All Rights Reserved

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COULTER ACT diff 2 Analyzer

PN 4237495BA (August 2010)

Beckman Coulter, Inc. 250 S. Kraemer Blvd. Brea, CA 92821

WARNINGS AND PRECAUTIONS

DELETING 4C PLUS CELL CONTROL FILES, 2-21

HOW TO USE YOUR COULTER ACT diff 2 ANALYZER MANUALS

INTRODUCTION ABOUT THIS MANUAL

ABOUT THIS MANUAL

Special Procedures and Troubleshooting

TOUCH SCREEN ICONS

INTRODUCTION TOUCH SCREEN ICONS

Main Screen Icons

Open Vial Whole Blood Mode

Closed Vial Whole Blood Mode

Sample Results Screen

INTRODUCTION TOUCH SCREEN ICONS

Setup Screen Icons

Print Setup Report

4C PLUS Cell Control Run

INTRODUCTION TOUCH SCREEN ICONS

Diluter Functions Screen Icons

Dispense Lytic Reagent

Dry Prime Lytic Reagent

Dry Prime Diluent

Diagnostic Functions Screen Icons

INTRODUCTION TOUCH SCREEN ICONS

Sample Results Screen Icons

Sample ID Screen Icons

Save and Exit

INTRODUCTION ICON TREE OVERVIEW

ICON TREE OVERVIEW

STARTUP SCREEN SETUP FUNCTIONS

ASSAY VALUES AND RANGES

CALIBRATION ASSIGNED VALUES

PULSE REPRODUCIBILITY RUN LATEX CALIBRATION CARRYOVER RUN PREPARE TO SHIP

ICON TREE DETAIL

ICON TREE DETAIL

STARTUP SCREEN (70)

MAIN SCREEN (10) SETUP FUNCTIONS STARTUP DILUTER FUNCTIONS

CLEAN BATHS DIAGNOSTICS FUNCTIONS DRY PRIME DILUENT

SHUTDOWN ANALYZING MODE SAMPLE RESULTS

(50) CALIBRATION ASSIGNED VALUES REPRODUCIBILITY RUN CARRYOVER RUN SAMPLE ID

SAMPLE DETAILS (51) PREPARE TO SHIP (42) (52) (58) (55)

(53 & 54))

(59) CALIBRATION RUN (56)

PULSE TEST (47) CARRYOVER SUMMARY

LATEX CALIBRATION RUN

ICON TREE DETAIL

At the Main screen, touch the Startup icon.

At the Main screen, touch the Shutdown icon.

ROUTINE PROCEDURES SHUTDOWN

Entering the Lot Number 1

CELL CONTROLS ENTERING 4C PLUS CELL CONTROL INFORMATION

At the Main screen, touch the QA icon.

At the QA screen, touch the 4C Management icon.

The square darkens next to your selection.

CELL CONTROLS ENTERING 4C PLUS CELL CONTROL INFORMATION

Enter the lot number: a. Touch the Lot# field.

Enter the lot number located on the vial (up to 6 digits).

P. EX C ) 2-8 F at 046 re 5 (3 Sto

Enter the expiration date: a. Touch the Exp. field.

Print the information you entered by touching the Print icon.

CELL CONTROLS ENTERING 4C PLUS CELL CONTROL INFORMATION